Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on May 08, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cervical Cancer
Intervention: pemetrexed disodium (Drug); chemotherapy (Procedure)
Phase: Phase 2
Status: Suspended
Sponsored by: Gynecologic Oncology Group Official(s) and/or principal investigator(s):
David S. Miller, MD, Study Chair, Affiliation: Simmons Cancer Center
Summary
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent cancer of the cervix.
Clinical Details
Official title:
A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231517, IND #40061) In the Treatment Of Recurrent Carcinoma Of The Cervix
Study design: Interventional, Treatment, Open Label
Detailed description:
OBJECTIVES:
* Determine the antitumor activity of pemetrexed disodium in patients with recurrent carcinoma of the cervix that failed higher priority treatment protocols.
* Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within 1-2 years.
Eligibility
Gender(s): Female.
Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed carcinoma of the cervix
- Squamous cell or non-squamous cell
- Recurrent disease
- Progressive disease
* Measurable disease
- At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by spiral CT scan
- Tumors within a previously irradiated field are considered non-target lesions unless disease progression is documented or a biopsy is obtained to confirm persistence at least 90 days after completion of radiotherapy
* Not amenable to surgery, radiotherapy, or other therapy
* Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent squamous cell or non-squamous cell carcinoma of the cervix
- Chemotherapy administered with primary radiotherapy as a radiosensitizer is not considered a systemic chemotherapy regimen
* Not eligible for a higher priority GOG protocol (i. e., any active phase III GOG protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* GOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm^3
* Platelet count ≥ 100,000/mm^3
* Hemoglobin ≥ 9 g/dL
Hepatic
* AST and ALT ≤ 3 times upper limit of normal (ULN)*
* Alkaline phosphatase ≤ 3 times ULN*
* Bilirubin ≤ 1. 5 times ULN NOTE: * ≤ 5 times ULN if liver metastases are present
Renal
* Creatinine clearance ≥ 45 mL/min
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study participation
* Neuropathy (sensory and motor) ≤ grade 1
* No active infection requiring antibiotics
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 weeks since prior biologic or immunologic agents for the malignant tumor
* At least 24 hours since prior growth factors
* One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following:
- Monoclonal antibodies
- Cytokines
- Small-molecule inhibitors of signal transduction
* No concurrent routine colony-stimulating factors
Chemotherapy
* See Disease Characteristics
* Recovered from prior chemotherapy
* No more than 1 prior cytotoxic chemotherapy regimen with either single or combination cytotoxic drug therapy
* No prior pemetrexed disodium
Endocrine therapy
* At least 1 week since prior hormonal therapy for the malignant tumor
* Concurrent hormone replacement therapy allowed
Radiotherapy
* See Disease Characteristics
* At least 2 weeks since prior radiotherapy and recovered
* No prior radiotherapy to > 25% of bone marrow
Surgery
* Recovered from prior surgery
Other
* At least 3 weeks since other prior therapy for the malignant tumor
* No nonsteroidal anti-inflammatory drugs for 2-5 days before, during, and for 1-2 days after study drug administration
- Concurrent daily low-dose (≤ 325 mg/day) aspirin therapy allowed
* No prior therapy that would contraindicate study participation
Locations and Contacts
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States
Doctors Medical Center, Modesto, California 95350-4138, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut 06105, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois 60521, United States
CCOP - Kansas City, Kansas City, Missouri 64131, United States
St. John's Regional Health Center, Springfield, Missouri 65804, United States
Women's Cancer Center - Las Vegas, Las Vegas, Nevada 89102, United States
SUNY Downstate Medical Center, Brooklyn, New York 11203, United States
SUNY Upstate Medical University Hospital, Syracuse, New York 13210, United States
Hope A Women's Cancer Center, Asheville, North Carolina 28801, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7295, United States
Case Comprehensive Cancer Center, Cleveland, Ohio 44106, United States
Hillcrest Cancer Center at Hillcrest Hospital, Mayfield Heights, Ohio 44124, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio 44109, United States
Cancer Care Associates - Midtown Tulsa, Tulsa, Oklahoma 74104, United States
Oklahoma University Medical Center, Oklahoma City, Oklahoma 73104, United States
Williamette Gynecologic Oncology P.C., Salem, Oregon 97301, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest, Allentown, Pennsylvania 18105, United States
Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania 19001, United States
M.D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas 75390, United States
Massey Cancer Center at Virginia Commonwealth University, Richmond, Virginia 23298-0037, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date:
August 2004
Last updated: February 20, 2007
|
