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

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Exatecan

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