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

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: exatecan mesylate

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein Clinical Cancer Center
    • New York, New York, United States, 10019
      • St. Luke's-Roosevelt Hospital
  • Ohio
    • Toledo, Ohio, United States, 43614
      • Ruppert Health Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Brookview Research, Inc.
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology PA (TOPA) at Baylor-Sammons
    • Houston, Texas, United States, 77030-4009
      • University of Texas - MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Actual): September 1, 2003
• Study Completion (Actual): September 1, 2003

Study Registration Dates

• First Submitted: March 7, 2000
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): May 16, 2012
• Last Update Submitted That Met QC Criteria: May 15, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: cervical squamous cell carcinoma; stage III cervical cancer; stage IV cervical cancer; recurrent cervical cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Exatecan
• Other Study ID Numbers: CDR0000067525; DAIICHI-8951A-PRT015; MDA-DM-99247