Conditions: Cervical Cancer
Keywords: cervical squamous cell carcinoma recurrent cervical cancer stage III cervical cancer stage IVA cervical cancer stage IVB cervical cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 55
Healthy volunteers: no

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.

Arms:
arm 1: Pemtrexed plus cisplatin on day 1 every 21 days

Interventions: intervention 1: cisplatin intervention 2: pemetrexed disodium
Intervention descriptions: intervention 1: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of intervention 2: None

Protocol document: