Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer

Basic Trial Information

Objectives

1. 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.
2. Assess the frequency and severity of toxic effects of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• 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)

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

Other:

• No prior treatment for this malignancy except surgical staging
• No prior anticancer therapy that would preclude study participation

Patient Characteristics:

Age:

• Not specified

Performance status:

• GOG 0-3

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 times normal
• Alkaline phosphatase no greater than 3 times normal
• SGOT no greater than 3 times normal

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• 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

Expected Enrollment

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

Outcomes

Recurrence-free interval
Overall survival
Frequency and severity of adverse events

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 observation.

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

Mannel RS, Brady MF, Kohn EC, et al.: A randomized phase III trial of IV carboplatin and paclitaxel × 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients with early-stage ovarian carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol 122 (1): 89-94, 2011.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Robert Mannel, MD, Protocol chair		Ph: 405-271-8787 Email: robert-mannel@ouhsc.edu

Southwest Oncology Group

David Alberts, MD, Protocol chair		Ph: 520-626-7685; 800-622-2673

Registry Information
Official Title		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
Trial Start Date		1998-10-23
Trial Completion Date		2010-03-15
Registered in ClinicalTrials.gov		NCT00003644
Date Submitted to PDQ		1998-10-28
Information Last Verified		2006-12-09
NCI Grant/Contract Number		CA27469

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