Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix

Cervical Cancer Clinical Trial

Official title:

A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231517, IND #40061) In the Treatment Of Recurrent Carcinoma Of The Cervix

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087113
• Other study ID #: GOG-0127T
• Secondary ID: LILLY-H3E-US-JMG
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2004
• Last updated: February 12, 2014
• Start date: August 2004

Study information

• Verified date: February 2014
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• pemetrexed disodium

Locations

Country	Name	City	State
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	Hope A Women's Cancer Center	Asheville	North Carolina
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Women's Cancer Center - Las Vegas	Las Vegas	Nevada
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio
United States	Doctors Medical Center	Modesto	California
United States	Oklahoma University Medical Center	Oklahoma City	Oklahoma
United States	Massey Cancer Center at Virginia Commonwealth University	Richmond	Virginia
United States	Williamette Gynecologic Oncology P.C.	Salem	Oregon
United States	St. John's Regional Health Center	Springfield	Missouri
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	Cancer Care Associates - Midtown Tulsa	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Miller DS, Blessing JA, Bodurka DC, Bonebrake AJ, Schorge JO; Gynecologic Oncology Group. Evaluation of pemetrexed (Alimta, LY231514) as second line chemotherapy in persistent or recurrent carcinoma of the cervix: a phase II study of the Gynecologic Oncol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antitumor activity			No
Primary	Toxicity			Yes