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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004866
• Other study ID #: CDR0000067525
• Secondary ID: DAIICHI-8951A-PR
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2000
• Last updated: May 15, 2012
• Start date: January 2000
• Est. completion date: September 2003

Study information

• Verified date: May 2012
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• exatecan mesylate

Locations

Country	Name	City	State
United States	Albert Einstein Clinical Cancer Center	Bronx	New York
United States	Texas Oncology PA (TOPA) at Baylor-Sammons	Dallas	Texas
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Brookview Research, Inc.	Nashville	Tennessee
United States	St. Luke's-Roosevelt Hospital	New York	New York
United States	Ruppert Health Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States,