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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00470405
Recruitment Status : Completed
First Posted : May 7, 2007
Last Update Posted : April 18, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Vanderbilt-Ingram Cancer Center

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
Lymphoma Solid Tumor Drug: oxaliplatin Drug: pemetrexed disodium Phase 1

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 lymphoma.

Secondary

  • Determine the quantitative and qualitative toxicities of this regimen in these patients.
  • Determine, preliminarily, the efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive pemetrexed disodium IV over 10 minutes and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of pemetrexed disodium and oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, the recommended phase II dose will be identified.

After completion of study treatment, patients are followed at 30 days and then periodically thereafter.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of ALIMTA Plus Oxaliplatin Administered Every Other Week in the Treatment of Patients With Metastatic Cancer
Study Start Date : May 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Therapeutic Intervention Drug: oxaliplatin
75-100 mg/m2 iv infusion Approximately 2 hours beginning approximately 30 minutes after the end of ALIMTA infusion on Day 1 of a 14-days cycle
Other Name: Elaxtin

Drug: pemetrexed disodium
a novel antifolate with multiple targets.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum tolerated dose
  2. Recommended phase II dose

Secondary Outcome Measures :
  1. Toxicity
  2. Efficacy

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470405


Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mace L. Rothenberg, MD, FACP Vanderbilt-Ingram Cancer Center
More Information
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Publications of Results:

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Responsible Party: Mace Rothenberg, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00470405    
Other Study ID Numbers: VICC PHI0367
VU-VICC-PHI-0367
LILLY-H3E-US-S053A
VU-IRB-031027
First Posted: May 7, 2007    Key Record Dates
Last Update Posted: April 18, 2011
Last Verified: April 2011
Keywords provided by Vanderbilt-Ingram Cancer Center:
adult solid tumor
unspecified adult solid tumor, protocol specific
stage IV adult Hodgkin lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
cutaneous B-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
adult nasal type extranodal NK/T-cell lymphoma
adult grade III lymphomatoid granulomatosis
Waldenstrom macroglobulinemia
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult immunoblastic large cell lymphoma
 stage IV adult lymphoblastic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
nodal marginal zone B-cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
recurrent adult grade III lymphomatoid granulomatosis
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Hodgkin lymphoma
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Oxaliplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors