A Limited Access Phase II Trial of Pemetrexed (Alimta, LY231514) (NSC #698037) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix
| City: |
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Orange |
| State: |
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California |
| Zip Code: |
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92868 |
| Conditions: |
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Cervical Cancer |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
- 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
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| NCT ID: |
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NCT00691301 |
| Primary Contact: |
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Study Chair
David S. Miller, MD
Simmons Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Orange, California 92868
United States
Clinical Trials Office - Chao Family Comprehensive Cancer Cent
Phone: 877-UC-STUDY
Email: ucstudy@uci.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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