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

This study has been suspended.

Sponsored by: Daiichi Pharmaceuticals
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
stage III cervical cancer
stage IV cervical cancer
recurrent cervical cancer
cervical squamous cell carcinoma
 Drug: exatecan mesylate
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of DX-8951f in Women With Advanced or Recurrent Squamous Cell Carcinoma of the Cervix

Further Study Details: 

OBJECTIVES:

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 above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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

Location Information


New York
      Albert Einstein Clinical Cancer Center, Bronx,  New York,  10461,  United States

      St. Luke's-Roosevelt Hospital, New York,  New York,  10019,  United States

Ohio
      Ruppert Health Center, Toledo,  Ohio,  43614,  United States

Tennessee
      Brookview Research, Inc., Nashville,  Tennessee,  37203,  United States

Texas
      Texas Oncology PA (TOPA) at Baylor-Sammons, Dallas,  Texas,  75246,  United States

      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Robert L. DeJager, MD, FACP,  Study Chair,  Daiichi Pharmaceuticals   

More Information

Study ID Numbers:  CDR0000067525; DAIICHI-8951A-PRT015; MDA-DM-99247
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004866
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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