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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert L. DeJager, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Sankyo Inc.

Authority:

United States: Federal Government

Study ID:

CDR0000067525

NCT ID:

NCT00004866

Start Date:

January 2000

Completion Date:

September 2003

Related Keywords:

  • Cervical Cancer
  • stage III cervical cancer
  • stage IV cervical cancer
  • recurrent cervical cancer
  • cervical squamous cell carcinoma
  • Neoplasms, Squamous Cell
  • Uterine Cervical Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Brookview Research, Inc.Nashville, Tennessee  37203
Albert Einstein Clinical Cancer CenterBronx, New York  10461
Texas Oncology PA (TOPA) at Baylor-SammonsDallas, Texas  75246
St. Luke's-Roosevelt HospitalNew York, New York  10019
Ruppert Health CenterToledo, Ohio  43614