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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004866
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 16, 2012
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: exatecan mesylate Phase 2

Detailed Description:


  • 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  (Clinical Trial)
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
Study Start Date : January 2000
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed advanced or recurrent squamous cell carcinoma of the cervix not curable by surgery or radiotherapy
  • Measurable disease
  • No known brain metastases



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3


  • 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)


  • Creatinine no greater than 2.0 mg/dL


  • No active congestive heart failure
  • No uncontrolled angina
  • No myocardial infarction within the past 6 months


  • 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


Biologic therapy:

  • No concurrent biologic therapy


  • 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


  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • At least 4 weeks since prior surgery
  • No concurrent surgery


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004866

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.
Study Chair: Robert L. DeJager, MD, FACP Daiichi Sankyo, Inc.

Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT00004866     History of Changes
Other Study ID Numbers: CDR0000067525
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 16, 2012
Last Verified: May 2012

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:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents