Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT ID: NCT00003560

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-05-31

Brief Summary

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.

PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating patients who have stage III or stage IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Detailed Description

OBJECTIVES:

• Evaluate the response rate, duration of response, and progression-free and overall survival of previously untreated patients with suboptimally debulked stage III or stage IV ovarian carcinoma, fallopian tube carcinoma, papillary serous cancer of the uterus, or primary peritoneal carcinoma treated with docetaxel and carboplatin.
• Evaluate the feasibility and toxicity of this regimen in these patients.
• Evaluate the effect of this regimen on quality of life of these patients.

OUTLINE: This is an open-label study.

Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed prior to therapy and then after every 3 courses of chemotherapy.

PROJECTED ACCRUAL: Approximately 14-40 patients will be accrued for this study within 2.5 years.

Conditions

Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

carboplatin

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-1

Life expectancy:

• More than 2 months

Hematopoietic:

• WBC greater than 3,000/mm3
• Platelet count greater than 100,000/mm3

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)
• SGOT and/or SGPT less than 2.5 times ULN OR
• SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN OR
• Alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT no greater than ULN
• No SGOT and/or SGPT greater than 1.5 times ULN with alkaline phosphatase greater than 2.5 times ULN
• Alkaline phosphatase less than 350 U/L

Renal:

• BUN less than 1.5 times normal
• Creatinine less than 1.5 times ULN

Other:

• No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or skin cancer
• No other serious medical or psychiatric illness
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormone therapy

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy

Surgery:

• See Disease Characteristics

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Herbert Irving Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Amy D. Tiersten, MD

Role: STUDY_CHAIR

Herbert Irving Comprehensive Cancer Center

Locations

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

CPMC-IRB-8437

Identifier Type: -

Identifier Source: secondary_id

NCI-V98-1467

Identifier Type: -

Identifier Source: secondary_id

CDR0000066624

Identifier Type: -

Identifier Source: org_study_id