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| Sponsor: | Daiichi Sankyo Inc. |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004866 |
Purpose
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: | Primary Purpose: 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.
Eligibility| 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:
Contacts and Locations| 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. |
More Information
| ClinicalTrials.gov Identifier: | NCT00004866 History of Changes |
| Other Study ID Numbers: | CDR0000067525, DAIICHI-8951A-PRT015, MDA-DM-99247 |
| Study First Received: | March 7, 2000 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
stage III cervical cancer stage IV cervical cancer recurrent cervical cancer cervical squamous cell carcinoma |
|
Neoplasms, Squamous Cell Uterine Cervical Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female Exatecan Camptothecin Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic |