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

NCT ID: NCT00004866

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2003-09-30

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.

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.

Conditions

Cervical Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

exatecan mesylate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert L. DeJager, MD, FACP

Role: STUDY_CHAIR

Daiichi Sankyo

Locations

St. Luke's-Roosevelt Hospital

New York, New York, United States

Albert Einstein Clinical Cancer Center

The Bronx, New York, United States

Ruppert Health Center

Toledo, Ohio, United States

Brookview Research, Inc.

Nashville, Tennessee, United States

Texas Oncology PA (TOPA) at Baylor-Sammons

Dallas, Texas, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

DAIICHI-8951A-PRT015

Identifier Type: -

Identifier Source: secondary_id

MDA-DM-99247

Identifier Type: -

Identifier Source: secondary_id

CDR0000067525

Identifier Type: -

Identifier Source: org_study_id