Status:
COMPLETED
Pemetrexed and Oxaliplatin in Treating Patients With Metastatic Solid Tumors or Lymphoma
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 gr...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose and the recommended phase II dose of pemetrexed disodium in combination with oxaliplatin in patients with metastatic solid tumors or lympho...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- No concurrent hormonal cancer therapy (except medroxyprogesterone)
- No other concurrent experimental medications (except thymidine)
- No other concurrent chemotherapy or immunotherapy
- No other concurrent anticancer therapy
- Concurrent palliative radiation therapy allowed for small areas of painful metastasis that cannot be managed adequately by systemic or local analgesics
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00470405
Start Date
May 1 2004
End Date
November 1 2007
Last Update
April 18 2011
Active Locations (1)
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1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838