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

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: exatecan mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00004866

MDA-DM-99247

CDR0000067525

DAIICHI-8951A-PRT015

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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