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

Gynecologic Oncology Group (GOG)

Status and phase

Completed

Phase 2

Conditions

Cervical Cancer

Treatments

Drug: cisplatin

Drug: pemetrexed disodium

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00691301

GOG-0076GG

CDR0000597154 (Other Identifier)

NCI-2009-00572 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

Female

Ages

Under 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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