Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

• Status: Completed
• Trial end date: 2003-05-01
• 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. It is not yet known whether receiving paclitaxel and carboplatin with epirubicin is more effective than paclitaxel and carboplatin alone for ovarian epithelial, fallopian tube, or peritoneal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin with or without epirubicin in treating patients who have stage IIB, stage III, or stage IV invasive ovarian epithelial, fallopian tube, or peritoneal cancer.

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

Details

• Lead Sponsor: Nordic Society for Gynaecologic Oncology; Nordic Society of Gynaecological Oncology - Clinical Trials Unit
• Collaborators: European Organisation for Research and Treatment of Cancer - EORTC; NCIC Clinical Trials Group
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Epirubicin; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven stage IIB, III, or IV invasive ovarian epithelial, fallopian tube, or peritoneal cancer

• No symptomatic brain metastasis

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• WHO/ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3

• Neutrophil count at least 1,500/mm^3

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

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal

Renal:

• Glomerular filtration rate at least 50 mL/min

Cardiovascular:

• No ventricular arrhythmia (LOWN class II or worse)

• No myocardial infarction within the past year

• No severe or uncontrolled hypertension

• No history of congestive heart disease (no New York Heart Association class III or IV heart disease) even if medically controlled

• LVEF at least 50%

Other:

• No other primary malignancies except carcinoma in situ of the cervix or basal cell skin cancer

• No worse than grade I preexisting motor or sensory neurologic pathology or symptoms

• No active infection or other serious underlying medical condition that would prevent compliance

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

• No other concurrent antineoplastic agents

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified