First-Line Treatment of Bevacizumab, Carboplatin, and Paclitaxel in Treating Participants With Stage III-IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01097746
Phase
PHASE2
Status
Completed

Conditions

  • FIGO Stage III Ovarian Cancer
  • FIGO Stage IIIA Ovarian Cancer
  • FIGO Stage IIIA1 Ovarian Cancer
  • FIGO Stage IIIA1(i) Ovarian Cancer
  • FIGO Stage IIIA1(ii) Ovarian Cancer
  • FIGO Stage IIIA2 Ovarian Cancer
  • FIGO Stage IIIB Ovarian Cancer
  • FIGO Stage IIIC Ovarian Cancer
  • FIGO Stage IVA Ovarian Cancer
  • FIGO Stage IVB Ovarian Cancer
  • Fallopian Tube Carcinoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Mucinous Adenocarcinoma
  • Fallopian Tube Serous Adenocarcinoma
  • Fallopian Tube Transitional Cell Carcinoma
  • Fallopian Tube Undifferentiated Carcinoma
  • Malignant Ovarian Brenner Tumor
  • Ovarian Clear Cell Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mucinous Adenocarcinoma
  • Ovarian Seromucinous Carcinoma
  • Ovarian Serous Adenocarcinoma
  • Ovarian Transitional Cell Carcinoma
  • Ovarian Undifferentiated Carcinoma
  • Primary Peritoneal Carcinoma
  • Primary Peritoneal Serous Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Carboplatin — DRUG
    Given IV
  • Paclitaxel — DRUG
    Given IV

Study Details

This phase II trial studies how well first-line treatment of bevacizumab, carboplatin, and paclitaxel work in treating participants with stage III- IV ovarian, primary peritoneal and fallopian tube cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and 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. Giving bevacizumab, carboplatin, and paclitaxel as first-line treatment may work better at treating ovarian, primary peritoneal, and fallopian tube cancer.

Key Dates

First listed
Apr 2, 2010
Start date
Apr 14, 2010
Status verified
Sep 2022
Primary completion
Dec 7, 2021
Completion
Sep 13, 2022

Study Design

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

Arms

  • Experimental: Treatment (paclitaxel, carboplatin, bevacizumab)
    Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With Treatment Success [ Time Frame: Up to 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-
MD Anderson Regional Care Center-KatyHoustonTexas77094-
MD Anderson Regional Care Center-Bay AreaNassau BayTexas77058-
MD Anderson Regional Care Center-Sugar LandSugar LandTexas77478-
MD Anderson Regional Care Center-The WoodlandsThe WoodlandsTexas77384-

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TXMD Anderson Regional Care Center-Katy· Houston, TXMD Anderson Regional Care Center-Bay Area· Nassau Bay, TXMD Anderson Regional Care Center-Sugar Land· Sugar Land, TXMD Anderson Regional Care Center-The Woodlands· The Woodlands, TX

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