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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00004866
First received: March 7, 2000
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Drug: exatecan mesylate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Study Start Date: January 2000
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004866

Locations
United States, New York
Albert Einstein Clinical Cancer Center
Bronx, New York, United States, 10461
St. Luke's-Roosevelt Hospital
New York, New York, United States, 10019
United States, Ohio
Ruppert Health Center
Toledo, Ohio, United States, 43614
United States, Tennessee
Brookview Research, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology PA (TOPA) at Baylor-Sammons
Dallas, Texas, United States, 75246
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
Study Chair: Robert L. DeJager, MD, FACP Daiichi Sankyo Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00004866     History of Changes
Other Study ID Numbers: CDR0000067525, DAIICHI-8951A-PRT015, MDA-DM-99247
Study First Received: March 7, 2000
Last Updated: May 15, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
stage III cervical cancer
stage IV cervical cancer
recurrent cervical cancer
cervical squamous cell carcinoma

Additional relevant MeSH terms:
Neoplasms, Squamous Cell
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Exatecan
Camptothecin
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on August 21, 2014