Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Completed · Phase 3

Conditions studied: Primary Peritoneal Carcinoma, Stage III Ovarian Cancer, Stage IV Ovarian Cancer

In brief

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is most effective in treating ovarian epithelial cancer and peritoneal cancer. Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have stage III or stage IV ovarian cancer or primary peritoneal cancer.

Key facts

Study ID

NCT00011986

Run by

Gynecologic Oncology Group

People needed

4312

Starts

2001-01-01

Expected to finish

2013-01-28

Last updated by the study team

2019-04-16

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed stage III or IV ovarian epithelial or serous primaryperitoneal carcinoma
• The following are ineligible:
• Germ cell tumors
• Sex cord-stromal tumors
• Carcinosarcomas
• Mixed Mullerian tumors or carcinosarcomas
• Metastatic carcinomas from other sites to theovary
• Low malignant potential tumors, including micropapillary serouscarcinomas
• Mucinous primary peritoneal carcinoma
• Prior ovarian low malignant potential tumor (borderline carcinoma) that was surgically resected with subsequent development of invasive adenocarcinoma allowed if no prior chemotherapy
• Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery
• Prior breast cancer allowed provided the following are true:
• Disease-free for more than 5 years
• No prior cytotoxic chemotherapy for breast cancer
• Prior or concurrent primary endometrial cancer allowed if the following conditions are met:
• Stage no greater than IB
• Less than 3 mm invasion without vascular or lymphatic invasion
• No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions
• Performance status - GOG 0-2
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN
• No acute hepatitis

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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