NCT00470405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 lymphoma

Timeline
Completed

Started May 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 18, 2011

Status Verified

April 1, 2011

Enrollment Period

3 years

First QC Date

May 3, 2007

Last Update Submit

April 14, 2011

Conditions

LymphomaSolid Tumor

Keywords

adult solid tumorunspecified adult solid tumor, protocol specificstage IV adult Hodgkin lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomacutaneous B-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomaadult nasal type extranodal NK/T-cell lymphomaadult grade III lymphomatoid granulomatosisWaldenstrom macroglobulinemiastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuestage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomanodal marginal zone B-cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomarecurrent adult grade III lymphomatoid granulomatosisrecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomasplenic marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarecurrent mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndrome

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose

  • Recommended phase II dose

Secondary Outcomes (2)

  • Toxicity

  • Efficacy

Study Arms (1)

Therapeutic Intervention

EXPERIMENTAL
Drug: oxaliplatinDrug: pemetrexed disodium

Interventions

oxaliplatinDRUG

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

Also known as: Elaxtin
Therapeutic Intervention
pemetrexed disodiumDRUG

a novel antifolate with multiple targets.

Therapeutic Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Publications (1)

  • 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.

    PMID: 18463792RESULT

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, T-Cell, CutaneousLymphoma, Extranodal NK-T-CellWaldenstrom MacroglobulinemiaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellMycosis FungoidesSezary Syndrome

Interventions

OxaliplatinPemetrexed

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphadenopathyNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLeukemiaLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Mace L. Rothenberg, MD, FACP

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 7, 2007

Study Start

May 1, 2004

Primary Completion

May 1, 2007

Study Completion

November 1, 2007

Last Updated

April 18, 2011

Record last verified: 2011-04

Locations

US(1)