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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Amy D. Tiersten, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066624

NCT ID:

NCT00003560

Start Date:

May 1998

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • endometrial papillary serous carcinoma
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Adenoma

Name

Location

Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032