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A Randomized, Prospective Phase III Comparison of Paclitaxel-Carboplatin Versus Docetaxel-Carboplatin as First Line Chemotherapy in Stage Ic-IV Epithelial Ovarian Cancer

Phase 3
18 Years
Open (Enrolling)
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

A Randomized, Prospective Phase III Comparison of Paclitaxel-Carboplatin Versus Docetaxel-Carboplatin as First Line Chemotherapy in Stage Ic-IV Epithelial Ovarian Cancer

OBJECTIVES: I. Compare the progression free survival of chemotherapy naive patients with
stage IC-IV ovarian epithelial cancer following initial surgery treated with paclitaxel and
carboplatin versus docetaxel and carboplatin. II. Compare the toxic effects of these
regimens in these patients. III. Determine the overall survival, overall response rate, and
CA125 response in these patients after these regimens. IV. Determine the quality of life of
these patients on these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by residual
disease (none or microscopic vs macroscopic no greater than 2 cm vs or macroscopic greater
than 2 cm), study center, FIGO stage (IC-IV), performance status (0 vs 1 vs 2), tumor grade
(well-defined vs moderately defined vs poorly defined/undifferentiated vs unknown), interval
debulking intention (yes vs no vs randomized into OV06 trial), elevated CA125 prior to
treatment (yes vs no), and primary peritoneal cancer (yes vs no). Patients may undergo
interval debulking surgery within 4 weeks of the third course of chemotherapy, or following
6 courses of treatment. Patients undergoing interval debulking after 3 courses should resume
chemotherapy within 3 weeks of surgery. Patients are randomized into one of two treatment
arms. Arm I: Patients receive paclitaxel IV over 3 hours, immediately followed by
carboplatin IV over 1 hour. Arm II: Patients receive docetaxel IV over 1 hour, immediately
followed by carboplatin IV over 1 hour. Courses are repeated every 21 days. Treatment
continues for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with partial or complete response may receive 3 additional courses of carboplatin
alone thereafter. Quality of life is assessed at baseline, prior to each treatment course,
and then every 4 months for 2 years or until disease progression. Patients are followed
every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then
every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 1050 patients will be accrued for this study within 2.25

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage IC-IV ovarian epithelial cancer IC
must have malignant cells in ascitic fluid or peritoneal washing, have tumor on surface of
the ovary, or have preoperative capsule rupture OR Peritoneal carcinomatosis
(ovarian-type) No evidence of primary fallopian tube carcinoma No mixed mesodermal tumors
No borderline ovarian tumors or tumors termed possibly malignant

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) OR ALT
or AST no greater than 1.5 times ULN OR Alkaline phosphatase no greater than 3 times ULN
Renal: Creatinine no greater than 1.25 times ULN Cardiovascular: No hypertension No
ischemic heart disease No myocardial infarction within the past 6 months No congestive
heart failure Other: Not pregnant or nursing Fertile patients must use effective
contraception No uncontrolled infection No other concurrent severe and/or uncontrolled
comorbid medical condition No prior malignancy within the past 5 years, except: Curatively
treated carcinoma in situ of the cervix Basal cell skin cancer No other concurrent
malignancy (e.g., endometrial cancer) No prior serious allergic reaction (e.g.,
anaphylactic shock) No symptomatic grade 2 or greater peripheral neuropathy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:
Prior surgery allowed

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Paul A. Vasey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Glasgow


United States: Federal Government

Study ID:




Start Date:

October 1998

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial