Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2003 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Herbert Irving Comprehensive Cancer Center
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003560
First received: November 1, 1999
Last updated: April 30, 2011
Last verified: September 2003
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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 Primary Peritoneal Cavity Cancer |
Drug: carboplatin Drug: docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
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
| ClinicalTrials.gov Identifier: | NCT00003560 History of Changes |
| Other Study ID Numbers: | CDR0000066624, CPMC-IRB-8437, NCI-V98-1467 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 30, 2011 |
| 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 serous carcinoma fallopian tube cancer primary peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases |
Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Docetaxel Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013