Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Conditions

• Clear Cell Adenocarcinoma
• 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
• Mucinous Adenocarcinoma
• Ovarian Brenner Tumor
• Ovarian Clear Cell Adenocarcinofibroma
• Ovarian Clear Cell Adenocarcinoma
• Ovarian Endometrioid Adenocarcinoma
• Ovarian Seromucinous Carcinoma
• Ovarian Serous Adenocarcinoma
• Ovarian Transitional Cell Carcinoma
• Ovarian Undifferentiated Carcinoma
• Primary Peritoneal Clear Cell Adenocarcinoma
• Primary Peritoneal Endometrioid Adenocarcinoma
• Primary Peritoneal Serous Adenocarcinoma
• Primary Peritoneal Transitional Cell Carcinoma
• Primary Peritoneal Undifferentiated Carcinoma
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma
• Undifferentiated Carcinoma

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Carboplatin — DRUG
  Given IV
• Docetaxel — DRUG
  Given IV
• Gemcitabine Hydrochloride — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Paclitaxel — DRUG
  Given IV
• Quality-of-Life Assessment — OTHER
  Ancillary studies

Study Details

This randomized phase III trial studies carboplatin, paclitaxel and gemcitabine hydrochloride when given together with or without bevacizumab after surgery to see how well it works in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer that has come back. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine hydrochloride 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. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer.

Key Dates

First listed

Nov 30, 2007

Start date

Dec 6, 2007

Status verified

Dec 2025

Primary completion

Apr 30, 2019

Completion

Jan 1, 2028

Study Design

Enrollment

1,052 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (paclitaxel, docetaxel, carboplatin)
  Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days.
• Experimental: Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab)
  Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days.
• Experimental: Arm III (gemcitabine hydrochloride, carboplatin)
  Patients receive gemcitabine hydrochloride IV over 60 minutes on days 1 and 8 and carboplatin as in Arm I.
• Experimental: Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin)
  Patients receive gemcitabine hydrochloride IV as in Arm III, bevacizumab IV and carboplatin IV as in Arm II.

Primary Outcome Measure

To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer [ Time Frame: The time frame is 82.5 months (median duration of follow-up) ]

Locations (680)

Find similar trials in Anchorage, AK

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