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

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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

Tracking Information
First Submitted Date  ICMJE May 3, 2007
First Posted Date  ICMJE May 7, 2007
Last Update Posted Date April 18, 2011
Study Start Date  ICMJE May 2004
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
  • Maximum tolerated dose
  • Recommended phase II dose
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
  • Toxicity
  • Efficacy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pemetrexed and Oxaliplatin in Treating Patients With Metastatic Solid Tumors or Lymphoma
Official Title  ICMJE A Phase I Study of ALIMTA Plus Oxaliplatin Administered Every Other Week in the Treatment of Patients With Metastatic Cancer
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma
  • Solid Tumor
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Therapeutic Intervention
Interventions:
  • Drug: oxaliplatin
  • Drug: pemetrexed disodium
Publications * Stover DG, Lockhart AC, Berlin JD, Chan E, Sandler AB, Sosman JA, Middlebrook V, Nicol S, Rothenberg ML. Phase I trial of pemetrexed plus oxaliplatin administered every other week in patients with metastatic cancer. Invest New Drugs. 2008 Aug;26(4):339-45. doi: 10.1007/s10637-008-9133-4. Epub 2008 May 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2010)
25
Original Enrollment  ICMJE
 (submitted: May 3, 2007)
36
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00470405
Other Study ID Numbers  ICMJE VICC PHI0367
VU-VICC-PHI-0367
LILLY-H3E-US-S053A
VU-IRB-031027
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mace Rothenberg, Vanderbilt-Ingram Cancer Center
Study Sponsor  ICMJE Vanderbilt-Ingram Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Mace L. Rothenberg, MD, FACP Vanderbilt-Ingram Cancer Center
PRS Account Vanderbilt-Ingram Cancer Center
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP