DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix
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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.
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 2 |
| 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 |
| Study Completion Date: | September 2003 |
| Primary Completion Date: | September 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the antitumor activity of DX-8951f in women with advanced or recurrent squamous cell carcinoma of the cervix.
- Evaluate the quantitative and qualitative toxic effects of this regimen in these patients.
- Evaluate the pharmacokinetics of this regimen in these patients.
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:
- Histologically confirmed advanced or recurrent squamous cell carcinoma of the cervix not curable by surgery or radiotherapy
- Measurable disease
- No known brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No active congestive heart failure
- No uncontrolled angina
- No myocardial infarction within the past 6 months
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent serious infection
- No other malignancy within the past 5 years except nonmelanomatous skin cancer
- No other life threatening illness
- No psychosis, mental disability, or incompetence
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic therapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy
- No more than 1 prior chemotherapy regimen (except chemotherapy for radiosensitization)
- No prior camptothecin
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- At least 4 weeks since prior surgery
- No concurrent surgery
Other:
- At least 4 weeks since other prior investigational drugs (including analgesics or antiemetics)
- No other concurrent investigational drugs during or within 28 days after final dose of study drug
- No concurrent drugs that induce or inhibit CYP3A enzyme
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
Additional Information:
No publications provided
| Responsible Party: | Daiichi Sankyo Inc. |
| 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: | May 15, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Daiichi Sankyo Inc.:
|
stage III cervical cancer stage IV cervical cancer recurrent cervical cancer cervical squamous cell carcinoma |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 19, 2013