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)

Part of paid clinical trials in Orange, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00085358
Phase
PHASE1
Status
Completed

Conditions

  • 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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • carboplatin — DRUG
    Given intraperitoneally
  • paclitaxel — DRUG
    Given IV or intraperitoneally
  • docetaxel — DRUG
    Given IV
  • bevacizumab — BIOLOGICAL
    Given IV

Study Details

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

Key Dates

First listed
Jun 11, 2004
Start date
May 31, 2004
Status verified
Jul 2019
Primary completion
May 31, 2011

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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 ]

Locations (16)

FacilityCityStateZIPSite coordinators
University of California Medical Center At Irvine-Orange CampusOrangeCalifornia92868-
Colorado Gynecologic Oncology GroupAuroraColorado80010-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-1470-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
Greater Baltimore Medical CenterBaltimoreMaryland21204-
Johns Hopkins UniversityBaltimoreMaryland21287-8936-
Washington University School of MedicineSt LouisMissouri63110-
Cooper Hospital University Medical CenterCamdenNew Jersey08103-
Case Western Reserve UniversityClevelandOhio44106-
Cleveland Clinic Cancer Center/Fairview HospitalClevelandOhio44111-
Lake University Ireland Cancer CenterMentorOhio44060-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Cancer Care Associates-MidtownTulsaOklahoma74104-
Cancer Care Associates-YaleTulsaOklahoma74136-1929-
Gynecologic Oncology GroupPhiladelphiaPennsylvania19103-
Women and Infants HospitalProvidenceRhode Island02905-

Find similar trials in Orange, CA

By research site
University of California Medical Center At Irvine-Orange Campus· Orange, CAColorado Gynecologic Oncology Group· Aurora, COUniversity of Chicago Comprehensive Cancer Center· Chicago, ILUniversity of Iowa Hospitals and Clinics· Iowa City, IAGreater Baltimore Medical Center· Baltimore, MDJohns Hopkins University· Baltimore, MD

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