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



Status:Completed
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 120
Updated:4/21/2016
Start Date:October 1998

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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

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.

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.

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
We found this trial at
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450 Clarkson Avenue
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Baltimore, Maryland 21231
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931 S. 9th Street
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666 Elm Street
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1025 Morehead Medical Dr # 600
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675 N Saint Clair St # 21-100
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115 Business loop 70 w
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3535 Olentangy River Road
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4100 John R
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125 Science Dr
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3551 Roger Brooke Dr
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