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Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsored by: Herbert Irving Comprehensive Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003560
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: carboplatin
Drug: docetaxel
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Docetaxel and Carboplatin for Suboptimally Debulked Stage III or Stage IV Ovarian and Fallopian Tube Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: May 1998
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003560

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
Investigators
Study Chair: Amy D. Tiersten, MD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066624, CPMC-IRB-8437, NCI-V98-1467
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003560     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
stage III endometrial carcinoma
stage IV endometrial carcinoma
endometrial papillary carcinoma
fallopian tube cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Fallopian Tube Cancer
Gonadal Disorders
Urogenital Neoplasms
Endometrial Cancer
Ovarian Diseases
Docetaxel
Genital Diseases, Female
Endometrial Neoplasms
Peritoneal Diseases
Uterine Neoplasms
Ovarian Cancer
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Uterine Diseases
Carboplatin
Abdominal Neoplasms
Ovarian Epithelial Cancer
Fallopian Tube Neoplasms
Carcinoma
Fallopian Tube Diseases
Digestive System Diseases
Carcinoma, Papillary
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms

Additional relevant MeSH terms:
Gonadal Disorders
Antineoplastic Agents
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Docetaxel
Endometrial Neoplasms
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Uterine Neoplasms
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Uterine Diseases
Carboplatin
Abdominal Neoplasms
Pharmacologic Actions
Fallopian Tube Neoplasms
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Peritoneal Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009