Two Different Schedules of Carboplatin, Paclitaxel, Gemcitabine, and Surgery in Treating Patients With Newly Diagnosed Stage IIIC or Stage IV Primary Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, gemcitabine, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known which treatment regimen may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving one of two chemotherapy regimens containing carboplatin, gemcitabine, and paclitaxel works in treating patients undergoing surgery for newly diagnosed primary stage IIIC or stage IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Warwick Medical School
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Gemcitabine; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Clinically, radiologically, and histologically confirmed diagnosis of 1 of the following:

• Primary epithelial ovarian cancer

• Primary peritoneal carcinoma

• Ovarian carcinosarcoma

• Fallopian tube carcinoma

• Newly diagnosed, stage IIIC/IV disease with or without ascites

• None of the following histologies allowed:

• Mucinous

• Classic clear cell

• Micropapillary or microacinar borderline tumors with or without invasive implants

• Unsuitable for primary debulking surgery, as defined by the following:

• Laparoscopic or other minor surgical-staging procedures

• Supplementary clinical and radiological assessments

• Presenting with factors affecting suitability for successful complete resection and necessarily prompting laparoscopic assessment, including any of the following:

• CT scan or MRI evidence of peritoneal carcinomatosis, extensive mesenteric infiltration, diaphragmatic involvement, extensive retroperitoneal involvement, and cytologically verified malignant pleural effusion and/or ascites

• Clinical evidence of ascites with radiological evidence of multisite disease

• Clinical evidence of pelvic infiltration and radiological evidence of multisite disease

• FIGO stage IV disease, including cervical/supraclavicular lymphadenopathy, intrahepatic parenchymal metastases, or cytologically confirmed malignant pleural effusion

• No known brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-3

• Life expectancy ≥ 3 months

• WBC > 3.0/mm³

• Platelet count ≥ 100,000/mm³

• ANC ≥ 1,500/mm³

• AST and ALT < 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase < 2.5 times ULN

• Bilirubin < 1.5 times ULN

• Estimated glomerular filtration rate ≥ 30 mL/min

• No diabetics, hypertensive smokers, or other patients with pre-existing occult neuropathic deficits

• No poorly controlled, potentially serious medical conditions, including any of the following:

• Cerebrovascular events within the past 12 months

• Severe chronic respiratory conditions requiring prior hospitalization

• Active infections

• Poorly controlled seizures

• Morbid psychiatric conditions likely to render treatment compliance with the protocol difficult

• No other malignancy treated with chemotherapy or radiotherapy except nonmelanoma skin cancer or carcinoma in situ of the cervix

• Prior malignancies disease-free for > 5 years not treated with chemotherapy allowed

• No other reasons likely to cause inability to comply with treatment schedule and follow-up

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics