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Sponsored by: |
Daiichi Sankyo Inc. |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004866 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating women who have advanced or recurrent cancer of the cervix.
Condition | Intervention | Phase |
---|---|---|
Cervical Cancer |
Drug: exatecan mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Advanced or Recurrent Squamous Cell Cancer of the Cervix |
Study Start Date: | January 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Albert Einstein Clinical Cancer Center | |
Bronx, New York, United States, 10461 | |
St. Luke's-Roosevelt Hospital | |
New York, New York, United States, 10019 | |
United States, Ohio | |
Ruppert Health Center | |
Toledo, Ohio, United States, 43614 | |
United States, Tennessee | |
Brookview Research, Inc. | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Texas Oncology PA (TOPA) at Baylor-Sammons | |
Dallas, Texas, United States, 75246 | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Robert L. DeJager, MD, FACP | Daiichi Sankyo Inc. |
Study ID Numbers: | CDR0000067525, DAIICHI-8951A-PRT015, MDA-DM-99247 |
Study First Received: | March 7, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004866 History of Changes |
Health Authority: | United States: Federal Government |
stage III cervical cancer stage IV cervical cancer recurrent cervical cancer cervical squamous cell carcinoma |
Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms DX 8951 Squamous Cell Carcinoma Recurrence Carcinoma |
Uterine Cervical Neoplasms Genital Diseases, Female Uterine Cervical Diseases Epidermoid Carcinoma Uterine Neoplasms Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Genital Neoplasms, Female Uterine Diseases Enzyme Inhibitors Urogenital Neoplasms DX 8951 Pharmacologic Actions |
Uterine Cervical Neoplasms Genital Diseases, Female Neoplasms Uterine Cervical Diseases Neoplasms by Site Therapeutic Uses Uterine Neoplasms Antineoplastic Agents, Phytogenic |