Clinical trial NCT00004866: DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: stage III cervical cancer
stage IV cervical cancer
recurrent cervical cancer
cervical squamous cell carcinoma
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein Clinical Cancer Center
state: New York
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital
state: New York
city: Toledo
country: United States
facility: Ruppert Health Center
state: Ohio
city: Nashville
country: United States
facility: Brookview Research, Inc.
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology PA (TOPA) at Baylor-Sammons
state: Texas
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Daiichi Sankyo
name: Robert L. DeJager, MD, FACP
role: STUDY_CHAIR
References: