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

Ovarian Cancer Clinical Trial

Official title:

A Phase II Study of Docetaxel and Carboplatin for Suboptimally Debulked Stage III or Stage IV Ovarian and Fallopian Tube Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003560
• Other study ID #: CDR0000066624
• Secondary ID: CPMC-IRB-8437NCI
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: January 3, 2014
• Start date: May 1998

Study information

• Verified date: September 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed previously untreated ovarian cancer, fallopian tube carcinoma, papillary serous cancer of the uterus, or primary peritoneal carcinoma

• Suboptimally debulked stage III or suboptimally or optimally debulked stage IV

• Measurable or evaluable disease

• CNS lesions, lytic bone lesions, and radiated lesions (unless there is documented progression after radiotherapy) are not considered measurable

• CA 125 levels above 49 units/mL in the absence of cirrhosis or nonmalignant gross ascites are considered evaluable

• Ineligible for other high-priority national or institutional study

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• carboplatin

• docetaxel

Locations

Country	Name	City	State
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Herbert Irving Comprehensive Cancer Center

Country where clinical trial is conducted

United States,