DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix

Sponsor

Daiichi Sankyo, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00004866

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cervical Cancer	Drug: exatecan mesylate	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

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 :

Jan 1, 2000

Actual Primary Completion Date :

Sep 1, 2003

Actual Study Completion Date :

Sep 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Albert Einstein Clinical Cancer Center	Bronx	New York	United States	10461
2	St. Luke's-Roosevelt Hospital	New York	New York	United States	10019
3	Ruppert Health Center	Toledo	Ohio	United States	43614
4	Brookview Research, Inc.	Nashville	Tennessee	United States	37203
5	Texas Oncology PA (TOPA) at Baylor-Sammons	Dallas	Texas	United States	75246
6	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030-4009