ClinicalTrials.gg
CompletedNCT02020707Updated Jul 26, 2024

Nab-Paclitaxel and Bevacizumab in Treating Patients With Unresectable Stage IV Melanoma or Gynecological Cancers

A Phase 1 interventional study of Bevacizumab and Laboratory Biomarker Analysis in Cervical Adenocarcinoma, Cervical Adenosarcoma and Cervical Adenosquamous Carcinoma, sponsored by Mayo Clinic. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-26.

Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2024, 2 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase I trial studies the side effects and best dose of nab-paclitaxel and bevacizumab in treating patients with stage IV melanoma that cannot be removed by surgery (unresectable), cancer of the cervix, endometrium, ovary, fallopian tube or peritoneal cavity. Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may stop or slow tumor growth by blocking the growth of new blood vessels necessary for tumor growth. Giving nab paclitaxel and bevacizumab may kill more tumor cells than nab-paclitaxel alone.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine the maximally tolerated dose (MTD-malignant melanoma [MM]) of Abraxane (nab-paclitaxel)/bevacizumab-complex (AB-complex) among patients with metastatic malignant melanoma.

II. To determine the maximally tolerated dose (MTD-gynecologic [GYN]) of AB-complex among patients with gynecologic cancers.

III. To further assess the safety profile and anti-tumor activity of the recommended phase II dose of AB-complex for patients with previously-treated endometrial cancer IV. To further assess the safety profile and anti-tumor activity of the recommended phase II dose of AB-complex for patients with previously treated ovarian cancer

SECONDARY OBJECTIVES:

I. To gather preliminary data on tumor response rate and progression free survival time of AB-complex among patients with metastatic malignant melanoma.

II. To gather preliminary data on tumor response rate and progression free survival time of AB-complex among patients with gynecologic cancers.

CORRELATIVE OBJECTIVES (DOSE-ESCALATION COHORTS ONLY):

I. Pharmacokinetics of paclitaxel administered in the context of AB-complex. II. Tumor concentrations of paclitaxel 24 hour (h) following AB-complex infusion and correlation with plasma levels.

OUTLINE: This is a dose-escalation study.

Patients receive nab-paclitaxel/bevacizumab-complex intravenously (IV) over 30-60 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient may receive paclitaxel if supply of nab-paclitaxel is exhausted.

After completion of study treatment, patients are followed up every 6 months for 12 months.

02

Conditions studied

  • Cervical Adenocarcinoma
  • Cervical Adenosarcoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Carcinosarcoma
  • Cervical Squamous Cell Carcinoma
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Endometrial Adenosquamous Carcinoma
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Endometrioid Adenocarcinoma
  • Endometrial Mixed Cell Adenocarcinoma
  • Endometrial Mucinous Adenocarcinoma
  • Endometrial Serous Adenocarcinoma
  • Endometrial Undifferentiated Carcinoma
  • Fallopian Tube Adenocarcinoma
  • Fallopian Tube Carcinosarcoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Mucinous Adenocarcinoma
  • Fallopian Tube Serous Adenocarcinoma
  • Fallopian Tube Squamous Cell Carcinoma
  • Fallopian Tube Transitional Cell Carcinoma
  • Fallopian Tube Undifferentiated Carcinoma
  • Malignant Female Reproductive System Neoplasm
  • Malignant Ovarian Clear Cell Tumor
  • Malignant Ovarian Endometrioid Tumor
  • Malignant Ovarian Epithelial Tumor
  • Malignant Ovarian Mucinous Tumor
  • Malignant Peritoneal Neoplasm
  • Malignant Solid Neoplasm
  • Ovarian Carcinosarcoma
  • Ovarian Clear Cell Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian High Grade Serous Adenocarcinoma
  • Ovarian Mucinous Adenocarcinoma
  • Ovarian Serous Adenocarcinoma
  • Ovarian Transitional Cell Carcinoma
  • Ovarian Undifferentiated Carcinoma
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Platinum-Sensitive Ovarian Carcinoma
  • Primary Peritoneal Carcinosarcoma
  • Primary Peritoneal Clear Cell Adenocarcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Primary Peritoneal Transitional Cell Carcinoma
  • Primary Peritoneal Undifferentiated Carcinoma
  • Unresectable Melanoma
  • Uterine Corpus Carcinosarcoma
03

In context

Adenocarcinoma, Clear Cell

46 studies on the registry are indexed under Adenocarcinoma, Clear Cell; 8 are open to participants now.

This study's enrollment of 43 is close to the median of 47 across 42 interventional studies indexed under Adenocarcinoma, Clear Cell.

Browse Adenocarcinoma, Clear Cell studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age >= 18 years
  • Melanoma cohort only: histologic proof of surgically unresectable stage IV malignant melanoma
  • Melanoma cohort only: defined as at least one lesion whose longest diameter can be accurately measured as >= 2.0 cm with chest x-ray, or as >= 1.0 cm with computed tomography (CT) scan or magnetic resonance imaging (MRI) scan; or CT component of a positron emission tomography (PET)/CT; NOTE: disease that is measurable by physical examination only is not eligible
  • Gynecologic cancer cohorts only (dose escalation and dose expansion cohorts)

    • Dose escalation cohort only: Histologic proof of epithelial cervical, endometrial, ovarian, fallopian, or primary peritoneal cancers; allowable histologies for cervical cancer include squamous cell carcinoma, adenocarcinoma, and mixed/adenosquamous carcinoma; allowable histologies for endometrial cancer include endometrioid, serous, clear cell, mucinous, squamous, transitional cell, undifferentiated, mixed, and carcinosarcoma (this is considered a poorly differentiated epithelial tumor); allowable histologies for ovarian, fallopian, and peritoneal cancer include serous, clear cell, endometrioid, mucinous, transitional cell, undifferentiated, mixed, and carcinosarcoma
  • Endometrial cancer expansion cohort only:

    • Histologic proof of endometrial cancer including endometrioid, serous, clear cell, mucinous, undifferentiated, mixed, and carcinosarcoma histologies
    • 1-3 lines of cytotoxic or therapy (not including hormonal therapy or other regimens not containing cytotoxic agents or immune checkpoint inhibitors)

      • If one (1) , must have contained a taxane, a platinum drug, and and immune checkpoint inhibitor
      • If 2-3 prior lines of therapy, at least one must have contained a taxane and a platinum drug, and at least one must have contained an immune checkpoint inhibitor
  • Ovarian cancer expansion cohort only:

    • Histologic proof of ovarian cancer including high grade serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, mixed, and carcinosarcoma histologies
    • 1-4 lines of cytotoxic chemotherapy (not including hormonal therapy or other non-cytotoxic regimens)

      • At least one prior line of chemotherapy must have contained a taxane and a platinum agent
      • If 1 or 2 prior lines of chemotherapy, patient's disease must be platinum-resistant

        • NOTE: Platinum-resistance is defined as any of the following occurring \< 183 days after the last dose of platinum-based chemotherapy:

          • Development of measurable disease (per [RECIST] 1.1)
          • Progression of radiographic disease (per RECIST 1.1)
          • Increase in CA-125 level to >= 2 x (ULN) (if within normal limits [WNL] at the completion of platinum-based chemotherapy)

            • If CA-125 is used to determine the date of progression then it must be confirmed by a second CA-125 value >= 7 days after the first level; the date of the first qualifying CA-125 is used to compute the platinum-free interval
          • Increase in CA-125 level to >= 2 x nadir (if nadir > ULN)

            • If CA-125 is used to determine the date of progression then it must be confirmed by a second CA-125 value >= 7 days after the first level; the date of the first qualifying CA-125 is used to compute the platinum-free interval
      • If 3-4 prior lines of chemotherapy, may be platinum-resistant or platinum-sensitive
    • At least one prior line of cytotoxic chemotherapy must also have contained bevacizumab
  • Dose escalation cohort: For ovarian, fallopian tube, and peritoneal cancers only: Must meet criteria for one option below:

    • Platinum-resistant, defined as =\< 183 days from the date of the most recent dose of chemotherapy containing either carboplatin or cisplatin until the first evidence of cancer recurrence or progression (either symptoms directly attributable to cancer, radiographic recurrence of cancer, or cancer antigen 125 [CA-125] > 70), confirmed >= 7 days later (confirmation of elevated CA-125 may be beyond 183 days and still count as platinum-resistant)
    • Prior allergic reaction to carboplatin or cisplatin
  • Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as >= 2.0 cm with chest x-ray, or as >= 1.0 cm with CT scan or MRI scan; or CT component of a PET/CT; NOTE: Disease that is measurable by physical examination only is not eligible; EXCEPTION: Patients with ovarian, fallopian, or peritoneal cancer without measurable disease are eligible if two pretreatment CA125 values (documented on two occasions taken at least one week apart) are at least twice the upper limit of normal or twice the nadir value if pretreatment CA125 values never normalized.
  • At least one prior systematic therapy in the setting

    • NOTE: exception for patients with metastatic uveal or mucosal melanoma for which there are no effective/approved front line systemic treatments
  • >= 9.0 g/dL (patients may be transfused to meet hemoglobin [Hgb] requirement) (obtained =\< 14 days prior to registration)
  • (ANC) >= 1500/mm\^3 (obtained =\< 14 days prior to registration)
  • count (PLT) >= 100,000/mm\^3 (obtained =\< 14 days prior to registration)
  • Total =\< 1.5 mg/dL or direct bilirubin =\< 0.4 mg/dL (obtained =\< 14 days prior to registration)
  • Serum glutamic oxaloacetic transaminase () (aspartate aminotransferase [AST]) =\< 2.5 x ULN (obtained =\< 14 days prior to registration)
  • Creatinine =\< 1.5 x ULN (obtained =\< 14 days prior to registration)
  • Alkaline phosphatase =\< 2.5 x ULN (obtained =\< 14 days prior to registration)
  • Absence of proteinuria at screening as demonstrated by one of the following (obtained =\< 14 days prior to registration):

    • Urine protein/creatinine (UPC) ratio \< 1.0 at screening OR
    • Urine dipstick for proteinuria \< 2+ (patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =\< 1 g of protein in 24 hours to be eligible)
  • (ECOG) performance status (PS) 0 or 1
  • Sensory peripheral neuropathy =\< grade 1 (per [CTCAE] version [v.] 4.0)
  • Motor peripheral neuropathy = grade 0 (per CTCAE v. 4.0)
  • Ability to understand and the willingness to sign a written document
  • Willing to return to enrolling institution for follow-up 2-4 weeks after treatment discontinuation
  • >= 90 days (3 months)
  • Willing to provide blood samples for correlative research purposes
  • Negative pregnancy test done =\< 7 days prior to registration, for persons of only

Exclusion criteria

Exclusion Criteria:

  • Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending ; EXCEPTION: For platinum-resistant ovarian cancer, because nab-paclitaxel has known benefit, patients who may benefit from standard single agent chemotherapy are also eligible to participate
  • Prior therapy with an angiogenesis inhibitor =\< 28 days prior to registration
  • No more than 3 systemic therapies (cytotoxic or immunologic) =\< 2 years prior to registration
  • Melanoma cohort only: Treatment with ipilimumab =\< 6 months prior to registration.
  • Intravenous anti-cancer therapy or agents =\< 4 weeks prior to registration or non-intravenous anti-cancer therapy or investigational agents =\< 2 weeks prior to registration

    • Note: No is required for hormone-based therapies
  • Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations (e.g., drug addiction) that would limit compliance with study requirements
  • Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
  • History or indication of per MRI or CT at any time prior to registration

    • NOTE: Patients who have had primary therapy for brain metastasis (i.e. surgical resection, whole brain radiation, or SRT even if stable) are not eligible
  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:

    • Pregnant persons
    • Nursing persons
    • Persons of who are unwilling to employ adequate
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Other active =\< 3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
  • Other medical conditions including but not limited to:

    • History of liver disease such as cirrhosis, chronic active hepatitis, chronic persistent hepatitis or or C
    • Active infection requiring parenteral antibiotics
    • Immuno-compromised patients and patients known to be (HIV) positive and currently receiving antiretroviral therapy; NOTE: patients known to be HIV positive, but without clinical evidence of an state, are eligible for this trial
    • class II-IV congestive heart failure (serious cardiac arrhythmia requiring medication)
    • Myocardial infarction or unstable angina =\< 6 months prior to registration
    • Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
    • peripheral vascular disease
    • History of central nervous system (CNS) disease (e.g., primary brain tumor, vascular abnormalities, etc.), clinically significant stroke or (TIA) =\< 6 months prior to registration, seizures not controlled with standard medical therapy
    • History of hypertensive crisis or hypertensive encephalopathy
    • Conditions that increase the risk of venous thrombosis and/or pulmonary emboli including, but not limited to: prior history of deep venous thrombosis or pulmonary emboli, atrial fibrillation, paroxysmal atrial fibrillation, known and documented thrombophilia requiring long term anticoagulation therapy, permanent intravenous indwelling catheters, severe obesity ( [BMI] > 40)

      • Note: Patients with increased risk of venous thrombosis and/or pulmonary emboli and who are receiving anticoagulation with warfarin, low molecular weight heparin, or a direct anticoagulant are not excluded
  • For gynecologic cancer cohort only (dose escalation and dose expansion cohorts): Recurrent or progressive disease within 30 days of the last dose of weekly paclitaxel or nab-paclitaxel
  • History of inflammatory bowel disease requiring ongoing therapy
  • History of diverticulitis or pancreatitis =\< 6 months prior to registration
  • History of grade 3 or 4 bowel toxicity from =\< 12 weeks prior to registration
  • Invasive surgery =\< 6 weeks prior to registration, or planned elective invasive surgery during study treatment.

NOTE: Patients with recent minor surgical procedures with minimal risk for wound healing complications may register =\< 6 weeks after the procedure with documented approval by the surgical team

Terms in these criteria, in plain language(28)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Treatment (AB-complex)

    Patients receive nab-paclitaxel/bevacizumab-complex IV over 30-60 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient may receive paclitaxel if supply of nab-paclitaxel is exhausted.

    Biological: Bevacizumab · Other: Laboratory Biomarker Analysis · Drug: Nab-paclitaxel · Other: Pharmacological Study

Interventions

  • BiologicalBevacizumab

    Given IV

    Also known as: ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, MYL-1402O, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Zirabev

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • Given IV

    Also known as: ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel

  • OtherPharmacological Study

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Maximum tolerated dose (MTD

    Defined as the highest dose level among those under consideration where at most 1 of 6 patients develops a dose-limiting toxicity.

    Time frame: 28 days

Secondary outcomes

  1. Tumor response

    Defined as complete response or partial response on 2 consecutive evaluations at least 8 weeks apart. Will be assessed as the number of patients whose tumor has met the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria.

    Time frame: Up to 12 months

  2. Progression-free survival (PFS)

    PFS is defined as the time from study entry to the documentation of disease progression.

    Time frame: Time from study entry to the documentation of disease progression, assessed up to 12 months

  3. Overall survival (OS)

    OS is defined as the time from study entry to death due to any cause.

    Time frame: Time from study entry to death due to any cause, assessed up to 12 months

  4. Incidence of adverse events (soft tissue expansion cohort)

    The maximum grade of each type of adverse event will be recorded for each patient and the percentage of patients developing any degree of that adverse effect, as well as the percentage of patients developing a severe degree (grade 3 or higher) will be determined. Adverse Events will be defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Time frame: Up to 12 months

07

Study locations

4 sites
  • Mayo Clinic Hospital in Arizona
    Phoenix, Arizona 85054, United States
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2014 to primary completion in Jul 2024, 124 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2013
First posted
Dec 25, 2013
StartActual
Feb 24, 2014
Primary completionActual
Jul 18, 2024
CompletionActual
Jul 18, 2024
Last update
Jul 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02020707
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Dec 25, 2013
Start date
Feb 24, 2014
Primary completion
Jul 18, 2024
Completion
Jul 18, 2024
Last update
Jul 26, 2024

Study contacts

Matthew S. Block, M.D., Ph.D.
principal investigator · Mayo Clinic in Rochester

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Bevacizumab · Albumin-Bound Paclitaxel

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