Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

NCT ID: NCT00691301

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2014-07-31

Brief Summary

RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with cisplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving pemetrexed together with cisplatin and to see how well it works in treating patients with advanced, persistent, or recurrent cervical cancer.

Detailed Description

OBJECTIVES:

Primary

• To estimate the antitumor activity of pemetrexed disodium and cisplatin with objective tumor response (partial and complete response) in patients with advanced, persistent, or recurrent carcinoma of the cervix.
• To determine the nature and degree of toxicity of this regimen in these patients.

Secondary

• To determine the effects of this regimen on progression-free survival and overall survival.

OUTLINE: This is a multicenter study. Patients are stratified according to prior cisplatin therapy as a radiosensitizer (yes vs no).

Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1-4 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pemetrexed and cisplatin

Pemtrexed plus cisplatin on day 1 every 21 days

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of

pemetrexed disodium

Intervention Type: DRUG

Interventions

cisplatin

Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of

Intervention Type: DRUG

pemetrexed disodium

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous or nonsquamous cell carcinoma of the cervix

• Advanced, persistent, or recurrent disease
• Disease not amenable to curative therapy
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Must have ≥ 1 target lesion to be used to assess response

• Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days following completion of radiotherapy

PATIENT CHARACTERISTICS:

• GOG performance status 0-2
• Platelet count ≥ 100,000/mm^3
• ANC ≥ 1,500/mm^3
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Creatinine clearance ≥ 60 mL/min
• SGOT ≤ 2.5 times ULN (≤ 5 times ULN if due to hepatic metastases)
• Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if due to hepatic metastases)
• Negative pregnancy test
• Fertile patients must use effective contraception
• Neuropathy (sensory and motor) ≤ grade 1
• Able to take folic acid, vitamin B12, and dexamethasone according to study protocol
• No history of other invasive malignancies within the past 5 years, except nonmelanoma skin cancer
• No active infection requiring antibiotics with the exception of uncomplicated UTI
• No presence of third space fluid which cannot be controlled by drainage

PRIOR CONCURRENT THERAPY:

• Recovered from effects of recent surgery, radiotherapy, or other therapy
• At least 1 week since prior hormonal therapy directed at the malignant tumor
• At least 4 weeks since prior radiotherapy
• More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin and patient remains free of recurrent or metastatic disease
• No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of cervical cancer
• No prior radiotherapy to more than 25% of marrow-bearing areas
• No prior cancer treatment that contraindicates study treatment
• No prior cytotoxic drugs for advanced or recurrent carcinoma of the cervix

• Prior cisplatin as a radiosensitizer for primary treatment of disease allowed
• No nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates 2-5 days before, during, or for 2 days after receiving pemetrexed disodium

• No NSAIDS with a long half-life (e.g., naproxen, piroxicam, diflunisal, or nabumetone) 5 days before, during, and for 2 days after receiving pemetrexed disodium
• Concurrent hormone replacement therapy is permitted
• Concurrent daily low-dose acetylsalicylic acid therapy (≤ 325 mg/day) allowed
• Concurrent use of acetylsalicylic acid (up to 1.3 g/day) allowed

• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David S. Miller, MD

Role: STUDY_CHAIR

Simmons Cancer Center

Locations

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, United States

University of Mississippi Cancer Clinic

Jackson, Mississippi, United States

Women's Cancer Center - La Canada

Las Vegas, Nevada, United States

MetroHealth Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, United States

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, United States

Cancer Care Associates - Saint Francis Campus

Tulsa, Oklahoma, United States

Parkland Memorial Hospital

Dallas, Texas, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

Lyndon B. Johnson General Hospital

Houston, Texas, United States

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Carilion Gynecologic Oncology Associates

Roanoke, Virginia, United States

Countries

United States

Other Identifiers

GOG-0076GG

Identifier Type: -

Identifier Source: secondary_id

CDR0000597154

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2009-00572

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0076GG

Identifier Type: -

Identifier Source: org_study_id