Pemetrexed and Oxaliplatin in Treating Patients With Metastatic Solid Tumors or Lymphoma

Completed · Phase 1

Conditions studied: Lymphoma, Solid Tumor

In brief

RATIONALE: Pemetrexed may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with oxaliplatin may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed given together with oxaliplatin in treating patients with metastatic solid tumors or lymphoma.

Key facts

Study ID

NCT00470405

Run by

Vanderbilt-Ingram Cancer Center

People needed

25

Starts

2004-05-01

Expected to finish

2007-11-01

Last updated by the study team

2011-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologic or cytologic diagnosis of solid tumors or lymphoma
• Metastatic disease
• No curative or effective therapy exists
• Measurable or nonmeasurable disease
• No clinically relevant third-space fluid collections
• Fluid collections must be drained before study enrollment
• No leukemia
• No CNS metastases

You may not qualify if…

• ECOG performance status 0-2
• Life expectancy ≥ 12 weeks
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 3.0 times ULN (5 times ULN if liver has tumor involvement)
• Creatinine clearance ≥ 45 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study therapy
• No active infection or other serious illness that would preclude study participation
• No weight loss ≥ 10% within the past 6 weeks
• No peripheral neuropathy (e.g., diabetic neuropathy) ≥ CTC grade 1
• Must be able to take concurrent vitamin B12 and folic acid
• PRIOR CONCURRENT THERAPY:
• No more than 1 prior chemotherapy regimen for metastatic disease
• More than 12 months since prior adjuvant therapy
• More than 30 days since prior drug that has not received regulatory approval
• More than 30 days since prior radiation therapy and recovered (alopecia allowed)
• Prior standard postoperative adjuvant radiation therapy for rectal cancer allowed
• No prior radiation therapy to ≥ 25% of bone marrow
• No prior oxaliplatin or pemetrexed disodium
• No NSAIDs or acetylsalicylic acid 2 days before (5 days for long-acting agents [e.g., piroxicam]), during, and for 2 days after each dose of pemetrexed disodium
• No concurrent nonpalliative radiation therapy or surgery for cancer

Where it is running

• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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