Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AGO Study Group
• Collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR); Nordic Society for Gynaecologic Oncology; Nordic Society of Gynaecological Oncology - Clinical Trials Unit
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Gemcitabine; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of one of the following:

• Ovarian epithelial cancer

• FIGO stage IA/B G3, IC-IV

• Fallopian tube cancer

• Extra-ovarian papillary serous tumor

• The following are ineligible:

• Low malignant-potential ovarian tumors (borderline tumors)

• Non-epithelial ovarian tumors

• Mixed Mullerian tumors

• Must have had definitive surgery within the past 6 weeks

• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• WBC at least 3,000/mm^3 OR

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin greater than 10 mg/dL

Hepatic

• Bilirubin no greater than 2 times upper limit of normal

Renal

• Glomerular filtration rate at least 50 mL/min

Cardiovascular

• No congestive heart failure

• No myocardial infarction within the past 6 months

• No New York Heart Association class III or IV heart disease

• No prior atrial or ventricular arrhythmias

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior seizures or central nervous system disorder

• No prior severe hypersensitivity reaction to products containing Cremophor EL (e.g., cyclosporine or vitamin K)

• No known hypersensitivity to compounds chemically related to carboplatin, gemcitabine, or paclitaxel

• No preexisting motor or sensory neuropathy greater than grade 1

• No other malignancy within the past 5 years except:

• Malignancies cured by surgery alone

• Carcinoma in situ of the cervix

• Adequately treated basal cell skin cancer

• No complete bowel obstruction

• No other concurrent severe medical condition that would preclude study participation

• No dementia or significantly altered mental status that would preclude study participation

• No concurrent severe active infection

• Geographically accessible for treatment and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunotherapy

Chemotherapy

• No prior chemotherapy

• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy except:

• Hormone replacement therapy

• Antiemetic steroids

Radiotherapy

• No prior radiotherapy

• No concurrent radiotherapy

Surgery

• See Disease Characteristics

• Recovered from prior surgery

Other

• No other concurrent antineoplastic agents

• No other concurrent investigational drugs

• No other concurrent clinical trial enrollment