Pemetrexed, Cisplatin, and Vitamin B12 in Treating Patients With Mesothelioma of the Chest That Cannot Be Removed by Surgery
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Purpose
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 and vitamin B12 may kill more tumor cells.
PURPOSE: This phase II clinical trial is studying how well giving pemetrexed together with cisplatin and vitamin B12 works in treating patients with mesothelioma of the chest that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Dietary Supplement: vitamin B12 Drug: cisplatin Drug: pemetrexed disodium Genetic: gene expression analysis Other: laboratory biomarker analysis Other: pharmacological study |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma |
- Individual dosage-adapted protocol [ Designated as safety issue: No ]
- Relationship between pharmacokinetic and pharmacodynamic parameters [ Designated as safety issue: No ]
- Pharmacokinetics [ Designated as safety issue: No ]
- Pharmacogenetic variations (MTHFR, TS, GSTpi, ERCC1, XPD) [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2007 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Define an individually adapted (by dosage) protocol of pemetrexed disodium, cisplatin, and vitamin B12 in patients with unresectable pleural mesothelioma.
Secondary
- Determine the relationship between pharmacokinetic and pharmacodynamic parameters (hematologic and nonhematologic).
- Analyze the inter-individual pharmacokinetic variations and the influence of the covariables on the pharmacokinetics of pemetrexed disodium.
- Analyze the impact of pharmacogenetic (MTHFR, TS, GSTpi, ERCC1, XPD) variations on the toxicity of pemetrexed disodium.
- Validate a strategy of adapting dosage.
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive vitamin B12 intramuscularly on day -7 and then every 9 weeks until chemotherapy is completed.
Blood samples are collected during the first and third courses of chemotherapy. Samples are analyzed by pharmacogenetic (MTHFR, TS, GSTpi, ERCC1, xPD), pharmacokinetic, and other pharmacological methods.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically confirmed pleural mesothelioma
- Unresectable disease
Exclusion criteria:
- Clinically detected pleural effusion or ascites that cannot be controlled by drainage or other procedures
PATIENT CHARACTERISTICS:
Inclusion criteria:
- WHO performance status 0-2
- Life expectancy > 3 months
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine clearance > 45 mL/min
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Transaminases ≤ 3 times ULN (5 times ULN if liver metastases)
- Not pregnant or nursing
- Fertile patients of must use effective contraception during and for 6 months after completion of study treatment
Exclusion criteria:
- Hypersensitivity to pemetrexed disodium or any of its excipients
- Peripheral neuropathy ≥ grade 2
- Impossible to receive study therapy due to geographical, social, familial, or psychological reasons
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
- At least 28 days since prior radiotherapy (21 days for injected radiotherapy)
Exclusion criteria:
- Prior chemotherapy
- Prior yellow fever vaccine
- Inability to discontinue aspirin (> 1.3 g/day) or NSAIDs for 2 days prior to, during, and 2 days after day 1 of each course of study therapy
- Concurrent participation in another clinical study
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00541073 History of Changes |
| Other Study ID Numbers: | CDR0000564058, COL-ALIMESO, INCA-RECF0441, COL-2006-04 |
| Study First Received: | October 5, 2007 |
| Last Updated: | May 14, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
advanced malignant mesothelioma recurrent malignant mesothelioma |
Additional relevant MeSH terms:
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Pemetrexed Cisplatin Vitamin B 12 Hydroxocobalamin Vitamin B Complex Vitamins Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Micronutrients Growth Substances Hematinics Hematologic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 22, 2013