Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-01-08 @ 5:58 AM
Study NCT ID:
NCT00470405
Status:
COMPLETED
Last Update Posted:
2011-04-18
First Post:
2007-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pemetrexed and Oxaliplatin in Treating Patients With Metastatic Solid Tumors or Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D017728', 'term': 'Lymphoma, Large-Cell, Anaplastic'}, {'id': 'D007119', 'term': 'Immunoblastic Lymphadenopathy'}, {'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D054391', 'term': 'Lymphoma, Extranodal NK-T-Cell'}, {'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D009182', 'term': 'Mycosis Fungoides'}, {'id': 'D012751', 'term': 'Sezary Syndrome'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D000072281', 'term': 'Lymphadenopathy'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-14', 'studyFirstSubmitDate': '2007-05-03', 'studyFirstSubmitQcDate': '2007-05-03', 'lastUpdatePostDateStruct': {'date': '2011-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose'}, {'measure': 'Recommended phase II dose'}], 'secondaryOutcomes': [{'measure': 'Toxicity'}, {'measure': 'Efficacy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['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', 'recurrent adult immunoblastic large cell lymphoma', 'recurrent adult lymphoblastic lymphoma', 'recurrent cutaneous T-cell non-Hodgkin lymphoma', 'recurrent grade 1 follicular lymphoma', 'recurrent grade 2 follicular lymphoma', 'recurrent grade 3 follicular lymphoma', 'recurrent mantle cell lymphoma', 'splenic marginal zone lymphoma', 'recurrent marginal zone lymphoma', 'recurrent small lymphocytic lymphoma', 'recurrent mycosis fungoides/Sezary syndrome', 'stage IV mycosis fungoides/Sezary syndrome'], 'conditions': ['Lymphoma', 'Solid Tumor']}, 'referencesModule': {'references': [{'pmid': '18463792', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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.\n\nSecondary\n\n* Determine the quantitative and qualitative toxicities of this regimen in these patients.\n* Determine, preliminarily, the efficacy of this regimen in these patients.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients 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.\n\nCohorts 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.\n\nAfter completion of study treatment, patients are followed at 30 days and then periodically thereafter.\n\nPROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologic or cytologic diagnosis of solid tumors or lymphoma\n* Metastatic disease\n\n * No curative or effective therapy exists\n* Measurable or nonmeasurable disease\n* No clinically relevant third-space fluid collections\n\n * Fluid collections must be drained before study enrollment\n* No leukemia\n* No CNS metastases\n\nExclusion Criteria:\n\n* ECOG performance status 0-2\n* Life expectancy ≥ 12 weeks\n* ANC ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 9 g/dL\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* AST and ALT ≤ 3.0 times ULN (5 times ULN if liver has tumor involvement)\n* Creatinine clearance ≥ 45 mL/min\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months after completion of study therapy\n* No active infection or other serious illness that would preclude study participation\n* No weight loss ≥ 10% within the past 6 weeks\n* No peripheral neuropathy (e.g., diabetic neuropathy) ≥ CTC grade 1\n* Must be able to take concurrent vitamin B12 and folic acid\n\nPRIOR CONCURRENT THERAPY:\n\n* No more than 1 prior chemotherapy regimen for metastatic disease\n* More than 12 months since prior adjuvant therapy\n* More than 30 days since prior drug that has not received regulatory approval\n* More than 30 days since prior radiation therapy and recovered (alopecia allowed)\n* Prior standard postoperative adjuvant radiation therapy for rectal cancer allowed\n* No prior radiation therapy to ≥ 25% of bone marrow\n* No prior oxaliplatin or pemetrexed disodium\n* 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\n* No concurrent nonpalliative radiation therapy or surgery for cancer\n* No concurrent hormonal cancer therapy (except medroxyprogesterone)\n* No other concurrent experimental medications (except thymidine)\n* No other concurrent chemotherapy or immunotherapy\n* No other concurrent anticancer therapy\n* Concurrent palliative radiation therapy allowed for small areas of painful metastasis that cannot be managed adequately by systemic or local analgesics'}, 'identificationModule': {'nctId': 'NCT00470405', 'briefTitle': 'Pemetrexed and Oxaliplatin in Treating Patients With Metastatic Solid Tumors or Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'A Phase I Study of ALIMTA Plus Oxaliplatin Administered Every Other Week in the Treatment of Patients With Metastatic Cancer', 'orgStudyIdInfo': {'id': 'VICC PHI0367'}, 'secondaryIdInfos': [{'id': 'VU-VICC-PHI-0367'}, {'id': 'LILLY-H3E-US-S053A'}, {'id': 'VU-IRB-031027'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic Intervention', 'interventionNames': ['Drug: oxaliplatin', 'Drug: pemetrexed disodium']}], 'interventions': [{'name': 'oxaliplatin', 'type': 'DRUG', 'otherNames': ['Elaxtin'], 'description': '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', 'armGroupLabels': ['Therapeutic Intervention']}, {'name': 'pemetrexed disodium', 'type': 'DRUG', 'description': 'a novel antifolate with multiple targets.', 'armGroupLabels': ['Therapeutic Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232-6838', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Mace L. Rothenberg, MD, FACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Mace Rothenberg', 'oldOrganization': 'Vanderbilt-Ingram Cancer Center'}}}}