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

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: carboplatin; Drug: paclitaxel

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00003644

NCI-2012-02291

GOG-0175

SWOG-G0175

Details and patient eligibility

About

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 receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.

Full description

OBJECTIVES:

• 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 observation.

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.

Enrollment: 571 patients

Sex: Female

Ages: Under 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• GOG 0-3

Life expectancy:

• Not specified

Hematopoietic:

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

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

571 participants in 2 patient groups

Carboplatin, paclitaxel, low dose paclitaxel

Experimental group

Description:

carboplatin, paclitaxel followed by low dose paclitaxel 4 weeks later

Treatment:

Drug: paclitaxel

Drug: carboplatin

Carboplatin, paclitaxel

Active Comparator group

Description:

carboplatin, paclitaxel

Treatment:

Drug: paclitaxel

Drug: carboplatin