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

March 7, 2000
May 15, 2012
January 2000
September 2003   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00004866 on ClinicalTrials.gov Archive Site
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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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Cervical Cancer
Drug: exatecan mesylate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
September 2003
September 2003   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004866
CDR0000067525, DAIICHI-8951A-PRT015, MDA-DM-99247
Not Provided
Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
Not Provided
Study Chair: Robert L. DeJager, MD, FACP Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP