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Pemetrexed and Oxaliplatin in Treating Patients With Metastatic Solid Tumors or Lymphoma
This study has been completed.
Sponsors and Collaborators: Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00470405
  Purpose

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 Intervention Phase
Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Drug: oxaliplatin
Drug: pemetrexed disodium
Phase I

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Pemetrexed disodium Pemetrexed Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I/II Study of ALIMTA Plus Oxaliplatin Administered Every Other Week in the Treatment of Patients With Metastatic Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose [ Designated as safety issue: Yes ]
  • Recommended phase II dose [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Efficacy [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: May 2004
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470405

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Mace L. Rothenberg, MD, FACP Vanderbilt-Ingram Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000543763, VU-VICC-PHI-0367, LILLY-H3E-US-S053A, VU-IRB-031027
Study First Received: May 3, 2007
Last Updated: October 2, 2008
ClinicalTrials.gov Identifier: NCT00470405  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
recurrent adult immunoblastic large cell lymphoma

Study placed in the following topic categories:
Sezary syndrome
Hodgkin's disease
Hodgkin lymphoma, adult
Cutaneous T-cell lymphoma
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Sezary Syndrome
Lymphoma, B-Cell, Marginal Zone
Mycosis Fungoides
Lymphoma, large-cell, immunoblastic
Lymphoma, large-cell
Lymphoma, B-Cell
Lymphomatoid granulomatosis
Burkitt's lymphoma
Mycoses
Oxaliplatin
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, T-Cell
Lymphoma, Large-Cell, Immunoblastic
Neoplasm Metastasis
Lymphoma, Large-Cell, Anaplastic
Waldenstrom macroglobulinemia
Hodgkin Disease
Lymphoma
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Lymphomatoid Granulomatosis
Immunoproliferative Disorders
Leukemia, B-cell, chronic

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009