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A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma

Phase 3
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma


- Compare the progression-free interval and overall survival of patients with early stage
ovarian epithelial cancer treated with carboplatin and paclitaxel with or without
low-dose paclitaxel.

- Assess the frequency and severity of toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30
minutes. Treatment repeats every 21 days for 3 courses. Four weeks after the completion
of paclitaxel and carboplatin, patients receive low-dose paclitaxel IV over 1 hour once
a week for 24 weeks.

- Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30
minutes. Treatment repeats every 21 days for 3 courses. Patients then undergo

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 5.5 years.

Inclusion Criteria


- Histologically confirmed ovarian epithelial cancer of one of the following histologic
cell types:

- Serous adenocarcinoma

- Malignant Brenner's tumor

- Mucinous adenocarcinoma

- Endometrioid

- Adenocarcinoma

- Clear cell adenocarcinoma

- Undifferentiated carcinoma

- Transitional cell

- Mixed epithelial carcinoma

- Adenocarcinoma - not otherwise specified

- Meets 1 of the following criteria:

- Stage Ia or Ib, grade 3 or clear cell

- Stage Ic or II, all grades/histologies

- Complete surgical staging

- No tumors of low malignant potential (borderline tumors)



- Not specified

Performance status:

- GOG 0-3

Life expectancy:

- Not specified


- WBC at least 3,000/mm^3

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


- Bilirubin no greater than 1.5 times normal

- Alkaline phosphatase no greater than 3 times normal

- SGOT no greater than 3 times normal


- Creatinine no greater than 2.0 mg/dL


- No other invasive malignancies within the past 5 years except nonmelanoma skin cancer

- No major systemic medical illness expected to affect survival

- Body surface area no greater than 2.0


Biologic therapy:

- Not specified


- Not specified

Endocrine therapy:

- Not specified


- Not specified


- See Disease Characteristics


- No prior treatment for this malignancy except surgical staging

- No prior anticancer therapy that would preclude study participation

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Recurrence-free interval

Safety Issue:


Principal Investigator

Robert S. Mannel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Oklahoma College of Medicine


United States: Federal Government

Study ID:




Start Date:

October 1998

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • ovarian undifferentiated adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • Brenner tumor
  • Ovarian Neoplasms



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