CClinicalTrials.gg
CompletedNCT00079430Updated Jul 22, 2019

Paclitaxel, Bevacizumab And Adjuvant Intraperitoneal Carboplatin in Treating Patients Who Had Initial Debulking Surgery for Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

A Phase 1 interventional study of adjuvant therapy and paclitaxel in Brenner Tumor, Fallopian Tube Cancer and Ovarian Clear Cell Cystadenocarcinoma, sponsored by National Cancer Institute (NCI). Completed at 19 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-22.

Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
113
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

This phase I trial is studying the side effects and best dose of adjuvant intraperitoneal carboplatin when given together with paclitaxel and bevacizumab in treating patients who have undergone debulking surgery for stage II , stage III, or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin and paclitaxel in treating ovarian epithelial or primary peritoneal cancer, or fallopian tube cancer.

Read the detailed description

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of intraperitoneal carboplatin when administered with paclitaxel during course 1, in patients with stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer who had initial debulking surgery.

II. Determine the feasibility of this regimen in these patients. III. Determine the feasibility of adding IV bevacizumab to this regimen in courses 2-6.

SECONDARY OBJECTIVES:

I. Determine the toxicity profile of this regimen in these patients. II. Determine the toxicity profile of paclitaxel and bevacizumab IV in combination with intraperitoneal carboplatin in these patients.

III. Determine the response rate (in patients with measurable disease who are in the expanded cohort) and progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal carboplatin.

Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-40 patients are treated at that dose level.

Patients are followed every 3 months for 1 year.

02

Conditions studied

  • Brenner Tumor
  • Fallopian Tube Cancer
  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mixed Epithelial Carcinoma
  • Ovarian Mucinous Cystadenocarcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Undifferentiated Adenocarcinoma
  • Primary Peritoneal Cavity Cancer
  • Stage II Ovarian Epithelial Cancer
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 113 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) 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
Female
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer

    • Stage II-IV disease
  • The following histologic epithelial cell types are eligible:

    • Serous adenocarcinoma
    • Mucinous adenocarcinoma
    • Clear cell adenocarcinoma
    • Transitional cell carcinoma
    • Adenocarcinoma not otherwise specified
    • Endometrioid adenocarcinoma
    • Undifferentiated carcinoma
    • Mixed epithelial carcinoma
    • Malignant Brenner's tumor
  • Optimal (≤ 1 cm residual disease) OR suboptimal residual disease after initial debulking surgery (performed within the past 12 weeks)
  • Synchronous primary endometrial cancer OR prior history of endometrial cancer allowed provided all of the following are true:

    • Stage IB disease or less
    • Less than 3 mm invasion without vascular or lymphatic invasion
    • No poorly differentiated subtypes, including the following:

      • Papillary serous
      • Clear cell
      • Other FIGO grade 3 lesions
  • No epithelial tumors of low malignant potential (borderline tumors)
  • No CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or brain metastases by history or evidence upon physical examination within the past 6 months
  • Performance status - GOG 0-2
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • INR ≤ 1.5
  • PTT \< 1.2 times upper limit of normal (ULN)
  • No active bleeding or pathologic conditions carrying high risk of bleeding (e.g., known bleeding disorder, coagulopathy, or tumor involving major vessels)
  • AST ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • No acute hepatitis
  • Creatinine ≤ 2.0 mg/dL
  • Urine protein-creatinine ratio \< 1.0 OR protein 1.0 g by 24 hour urine collection
  • Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided the patient's cardiac status has been stable for ≥ 6 months before study entry
  • No clinically significant cardiovascular disease, including any of the following:

    • Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg
    • Myocardial infarction or unstable angina within the past 6 months
    • New York Heart Association class II-IV congestive heart failure
    • Serious cardiac arrhythmia requiring medication
    • Peripheral vascular disease ≥ CTCAE grade 2 (at least brief (\< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit)
    • No history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within the past 6 months
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of bevacizumab therapy
  • No neuropathy (sensory and motor) > grade 1
  • No active infection requiring antibiotics
  • No circumstances that would preclude study participation
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • No history of allergic reaction to polysorbate 80 (e.g., etoposide, vitamin E)
  • No other invasive malignancies within the past 5 years except non-melanoma skin cancer or localized breast cancer
  • No serious, non-healing wound, ulcer, or bone fracture
  • No significant traumatic injury within 28 days prior to bevacizumab therapy
  • No prior history of abdominal fistula or gastrointestinal perforation within the past 3-6 months

    • Granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection allowed but require weekly wound examinations
  • No clinical symptoms or signs of gastrointestinal obstruction requiring parenteral hydration and/or nutrition
  • At least 28 days since intra-abdominal abscess and recovered
  • At least 3 years since prior adjuvant chemotherapy for localized breast cancer

    • Patients must remain free of recurrent or metastatic disease
  • At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin

    • Patient must remain free of recurrent or metastatic disease
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis
  • No concurrent amifostine or other protective agents
  • No concurrent major surgical procedure or open biopsy or within 28 days prior to bevacizumab therapy
  • No core biopsy within 7 days prior to bevacizumab therapy
  • No prior therapy for this malignancy
  • No prior cancer treatment that contraindicates study therapy
  • No prior anti-VEGF drug, including bevacizumab
05

Study design

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

Study arms

  • Experimental
    Treatment (adjuvant, paclitaxel, carboplatin, bevacizumab)

    Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

    Procedure: adjuvant therapy · Drug: paclitaxel · Drug: carboplatin · Biological: bevacizumab

Interventions

  • Procedureadjuvant therapy
  • Drugpaclitaxel

    Given IV

    Also known as: Anzatax, Asotax, TAX, Taxol

  • Drugcarboplatin

    Given intraperitoneally

    Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

  • Biologicalbevacizumab

    Given IV

    Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

06

What researchers measure

Primary outcomes

  1. Maximum tolerated dose (MTD) of intraperitoneal carboplatin with intravenous paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)

    Time frame: 3 weeks

  2. Incidence of adverse events in patients given intraperitoneal carboplatin with intravenous paclitaxel at the MTD, assessed by CTCAE v3.0

    Time frame: 12 weeks

  3. Number of observed DLTs in patients given intraperitoneal carboplatin with intravenous paclitaxel and intravenous bevacizumab, graded using CTCAE v3.0

    Time frame: 6 weeks

Secondary outcomes

  1. Incidence of adverse events in patients given intraperitoneal carboplatin with intravenous paclitaxel and intravenous bevacizumab, graded using CTCAE v3.0

    Time frame: 12 weeks

  2. Response rate (in patients with measurable disease who are in the expanded cohort) assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

    Time frame: Up to 1 year

  3. Progression-free survival assessed by RECIST

    Time frame: From study entry until disease progression, death or date of last contact, up to 1 year

07

Study locations

19 sites
  • University of California Medical Center At Irvine-Orange Campus
    Orange, California 92868, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • Johns Hopkins University/Sidney Kimmel Cancer Center
    Baltimore, Maryland 21287, United States
  • Cooper Hospital University Medical Center
    Camden, New Jersey 08103, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • Riverside Methodist Hospital
    Columbus, Ohio 43214, United States
  • Cancer Care Associates-Midtown
    Tulsa, Oklahoma 74104, United States
  • Tulsa Cancer Institute
    Tulsa, Oklahoma 74146, United States
  • Gynecologic Oncology Group
    Philadelphia, Pennsylvania 19103, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • Women and Infants Hospital
    Providence, Rhode Island 02905, United States
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
  • Pacific Gynecology Specialists
    Seattle, Washington 98104, United States
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
  • Seattle Cancer Care Alliance
    Seattle, Washington 98109, United States
  • University of Washington Medical Center
    Seattle, Washington 98195, United States
  • Kawasaki Medical School
    Okayama-Ken, Kurashiki 701-0192, Japan
  • Saitama Medical University International Medical Center
    Saitama, 350-1298, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00079430
Lead sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group
Responsible party
Sponsor
First posted
Mar 10, 2004
Start date
Jun 2004
Primary completion
May 2011
Last update
Jul 22, 2019

Study contacts

Mark Morgan
principal investigator · Gynecologic Oncology Group
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

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

Start the discussion