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CompletedNCT00085358Updated Jul 22, 2019

Carboplatin and Paclitaxel With or Without Bevacizumab Compared to Docetaxel, Carboplatin, and Paclitaxel in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Carcinoma (Cancer)

A Phase 1 interventional study of carboplatin and paclitaxel in Brenner Tumor, Fallopian Tube Cancer and Ovarian Carcinosarcoma, sponsored by National Cancer Institute (NCI). Completed at 16 sites in United States. 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
40
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 intraperitoneal infusions of carboplatin when given together with intravenous infusions of either docetaxel or paclitaxel followed by intraperitoneal paclitaxel in treating patients with stage II, stage III, or stage IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma (cancer). Drugs used in chemotherapy, such as carboplatin, docetaxel, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells

Read the detailed description

OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) of intraperitoneal (IP) carboplatin when given in combination with IV paclitaxel followed by IP paclitaxel in patients with stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma.

II. Determine the MTD of IP carboplatin and IV docetaxel when given in combination with IP paclitaxel in these patients.

III. To determine the feasibility of the combination of IV paclitaxel, IP carboplatin and IV bevacizumab on day one followed by IP paclitaxel on day eight (Part C Only).

IV. Determine the dose-limiting toxic effects and complications in patients treated with these regimens.

V. Evaluate the neurotoxicity of this regimen at each cycle using the FACT/GOG-NTX4 assessment tool to determine dose reduction in these patients.

VI. Evaluate the techniques used for intraperitoneal catheter placement, surgical procedures, and reporting of outcomes in these patients.

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

Patients in the dose-escalation phase are not eligible to enter the feasibility phase.

DOSE-ESCALATION PHASE (PART A or PART B): Patients receive IP carboplatin on day 1, and paclitaxel IV over 3 hour (part A) or docetaxel IV over 1 hour (Part B) on day 1, and IP paclitaxel on day 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

FEASIBILITY PHASE (PART C): Patients receive IP carboplatin on day 1, paclitaxel IV on day 1, and IP paclitaxel on day 8 in course 1 as in part A dose-escalation phase. Beginning in course 2 and all subsequent courses, patients receive IP carboplatin on day 1, IV paclitaxel on day 1, and IP paclitaxel on day 8 as in the dose-escalation phase, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year.

02

Conditions studied

  • Brenner Tumor
  • Fallopian Tube Cancer
  • Ovarian Carcinosarcoma
  • 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 40 is below 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 fallopian tube, ovarian epithelial, or primary peritoneal carcinoma

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

      • Carcinosarcoma
      • Serous adenocarcinoma
      • Endometrioid adenocarcinoma
      • Mucinous adenocarcinoma
      • Undifferentiated carcinoma
      • Clear cell adenocarcinoma
      • Mixed epithelial carcinoma
      • Transitional cell carcinoma
      • Malignant Brenner's tumor
      • Adenocarcinoma not otherwise specified
  • Must have undergone prior surgery for ovarian or peritoneal carcinoma within the past 12 weeks

    • Optimal (≤ 1 cm residual disease) or suboptimal residual disease following initial surgery
    • Must have a procedure for determining diagnosis of ovarian/peritoneal carcinoma with appropriate tissue for histologic evaluation
  • Synchronous primary endometrial cancer or prior endometrial cancer allowed provided the following criteria are met:

    • Stage ≤ IB
    • Less than 3 mm invasion without vascular or lymphatic invasion
    • No poorly differentiated subtypes (e.g., grade 3, clear cell, or papillary serous)
  • No epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)
  • No CNS disease (e.g., seizures not controlled with standard medical therapy) or metastasis
  • GOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • INR ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thrombo-embolus) (applies to part C only)
  • PTT \< 1.2 times the upper limit of normal (applies to part C only)
  • SGOT ≤ 2.5 times normal
  • Alkaline phosphatase ≤ 2.5 times normal
  • Bilirubin ≤ 1.5 times normal
  • Creatinine ≤ 1.5 times normal
  • No active bleeding
  • Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed provided disease has remained stable for the past 6 months
  • No unstable angina or myocardial infarction within the past 6 months
  • No neuropathy (sensory and motor) > CTCAE grade 1
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for at least 6 months after completion of study therapy
  • No septicemia, severe infection, or acute hepatitis
  • No other invasive malignancy within the past 5 years except non-melanoma skin cancer or localized breast cancer
  • No circumstance that would preclude study participation
  • No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E)
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies (applies to part C only)
  • No clinically significant proteinuria

    • Must have urine protein-creatinine ratio (UPCR) \< 1
  • No serious, non-healing wound, ulcer, or bone fracture (applies to part C only)
  • At least 3-6 months since prior abdominal fistula or gastrointestinal perforation and fully recovered (part C only)
  • No history of intra-abdominal abscess within the past 28 days (applies to part C only)
  • No active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels (applies to part C only)
  • No history or evidence (upon physical examination) of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or brain metastases (applies to part C only)
  • No history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study (applies to part C only)
  • No significant traumatic injury within 28 days (applies to part C only)
  • No clinically significant cardiovascular disease, including any of the following (applies to part C only):

    • Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg
    • Myocardial infarction or unstable angina \< 6 months prior to registration
    • New York Heart Association (NYHA) Grade II or greater congestive heart failure
    • Serious cardiac arrhythmia requiring medication
    • CTCAE Grade 2 or greater peripheral vascular disease (at least brief (\< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit)
    • History of CVA within the past six months
  • No clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition (applies to part C only)
  • No prior therapy with any anti-VEGF drug, including bevacizumab (applies to part C only)
  • No prior chemotherapy

    • Prior adjuvant chemotherapy for localized breast cancer allowed provided the therapy was completed at least 3 years before registration to study and the patient remains free of recurrent or metastatic disease
  • No prior radiotherapy
  • No prior cancer therapy that would contraindicate study treatment
  • No anticipation of invasive procedures, including any of the following (applies to part C only):

    • Major surgical procedure or open biopsy within 28 days prior to the first date of bevacizumab therapy (cycle 2)
    • Major surgical procedure anticipated during the course of the study
    • Core biopsy within 7 days prior to the first date of bevacizumab therapy
05

Study design

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

Study arms

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

    Patients receive IP carboplatin on day 1, and paclitaxel IV over 3 hour (part A) or docetaxel IV over 1 hour (Part B) on day 1, and IP paclitaxel on day 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive IP carboplatin on day 1, paclitaxel IV on day 1, and IP paclitaxel on day 8 in course 1 as in part A dose-escalation phase. Beginning in course 2 and all subsequent courses, patients receive IP carboplatin on day 1, IV paclitaxel on day 1, and IP paclitaxel on day 8 as in the dose-escalation phase, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

    Drug: carboplatin · Drug: paclitaxel · Drug: docetaxel · Biological: bevacizumab

Interventions

  • Drugcarboplatin

    Given intraperitoneally

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

  • Drugpaclitaxel

    Given IV or intraperitoneally

    Also known as: Anzatax, Asotax, TAX, Taxol

  • Drugdocetaxel

    Given IV

    Also known as: RP 56976, Taxotere, TXT

  • 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 IV paclitaxel with IP carboplatin followed by IP 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. MTD of IV docetaxel with IP carboplatin followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using CTCAE v3.0

    Time frame: 3 weeks

  3. MTD of IV paclitaxel with IP carboplatin and IV bevacizumab followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using CTCAE v3.0

    Time frame: 3 weeks

Secondary outcomes

  1. Incidence of adverse events in patients given IV paclitaxel with IP carboplatin followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0

    Time frame: 12 weeks

  2. Incidence of adverse events in patients given of IV docetaxel with IP carboplatin followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0

    Time frame: 12 weeks

  3. Incidence of adverse events in patients given IV paclitaxel with IP carboplatin and IV bevacizumab followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0

    Time frame: 12 weeks

07

Study locations

16 sites
  • University of California Medical Center At Irvine-Orange Campus
    Orange, California 92868, United States
  • Colorado Gynecologic Oncology Group
    Aurora, Colorado 80010, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637-1470, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • Greater Baltimore Medical Center
    Baltimore, Maryland 21204, United States
  • Johns Hopkins University
    Baltimore, Maryland 21287-8936, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Cooper Hospital University Medical Center
    Camden, New Jersey 08103, United States
  • Case Western Reserve University
    Cleveland, Ohio 44106, United States
  • Cleveland Clinic Cancer Center/Fairview Hospital
    Cleveland, Ohio 44111, United States
  • Lake University Ireland Cancer Center
    Mentor, Ohio 44060, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
  • Cancer Care Associates-Midtown
    Tulsa, Oklahoma 74104, United States
  • Cancer Care Associates-Yale
    Tulsa, Oklahoma 74136-1929, United States
  • Gynecologic Oncology Group
    Philadelphia, Pennsylvania 19103, United States
  • Women and Infants Hospital
    Providence, Rhode Island 02905, United States
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
NCT00085358
Lead sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group
Responsible party
Sponsor
First posted
Jun 11, 2004
Start date
May 2004
Primary completion
May 2011
Last update
Jul 22, 2019

Study contacts

Joan Walker
principal investigator · Gynecologic Oncology Group
View the source record on ClinicalTrials.gov ↗

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

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