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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003956 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of SCH 66336, fluorouracil, and leucovorin in treating patients who have advanced cancer.
Condition | Intervention | Phase |
---|---|---|
Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: fluorouracil Drug: leucovorin calcium Drug: lonafarnib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Continuous Oral Administration of SCH 66336 and 5-Fluorouracil/Leucovorin (5FU/LV) in Patients With Advanced Cancer |
Estimated Enrollment: | 25 |
Study Start Date: | April 1999 |
OBJECTIVES: I. Determine the safety, tolerability, maximum tolerated dose, and dose limiting toxicity of oral SCH 66336 with fluorouracil and leucovorin calcium in patients with advanced malignancy. II. Assess the multiple dose pharmacokinetics of oral SCH 66336 when administered with fluorouracil and leucovorin calcium. III. Assess the pharmacokinetics of fluorouracil when administered with oral SCH 66336. IV. Assess antitumor activity of oral SCH 66336 with fluorouracil and leucovorin calcium in these patients.
OUTLINE: This is a dose escalation study of SCH 66336. Patients receive oral SCH 66336 twice daily for 56 days.
Patients receive leucovorin calcium IV over 1-2 minutes immediately followed by fluorouracil IV over 1-2 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SCH 66336. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT) during course 1, with at least 2 patients experiencing DLT at the next higher level.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven malignancy for which no curative therapy exists At least 1 bidimensionally measurable lesion No acute or chronic leukemia or multiple myeloma No active CNS metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG-WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 3 times upper limit of normal (ULN) (5 times ULN if elevations due to liver metastasis) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No prior or concurrent QTc interval prolongation greater than 500 m/sec, unless approved by cardiology consult prior to study Other: No malabsorption syndrome due to surgery, prior disease, or other unknown reason No frequent vomiting or other medical condition that could interfere with oral medicine intake (e.g., partial bowel obstruction, external biliary diversion) No concurrent nonmalignant systemic disease making patient a poor risk for study No active uncontrolled infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No prior allogeneic, syngeneic, or autologous bone marrow transplantation No prior peripheral blood stem cell transplantation No concurrent biologic therapy Chemotherapy: No more than 2 prior chemotherapy regimens At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) and recovered No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior wide field radiation (radiotherapy to at least 25% of bone marrow, including pelvic irradiation) No concurrent radiotherapy Surgery: Prior major gastrointestinal surgery allowed if recovered Other: At least 4 weeks since other prior investigational therapy and recovered
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Leonard B. Saltz, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000067155, MSKCC-99020, SPRI-C98-564-01, NCI-G99-1540 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003956 History of Changes |
Health Authority: | United States: Federal Government |
stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma unspecified adult solid tumor, protocol specific stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma stage IV adult T-cell leukemia/lymphoma recurrent adult T-cell leukemia/lymphoma AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma stage IV mantle cell lymphoma recurrent mantle cell lymphoma angioimmunoblastic T-cell lymphoma anaplastic large cell lymphoma recurrent marginal zone lymphoma |
Antimetabolites Immunologic Factors Lymphoma, Mantle-Cell Lymphoma, Follicular Leucovorin Central Nervous System Lymphoma, Primary Mantle Cell Lymphoma Lymphoma, B-Cell, Marginal Zone Lymphoblastic Lymphoma Follicular Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia Leukemia, Lymphocytic, Chronic, B-Cell |
Vitamins Lymphoma, T-Cell Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-Cell, Anaplastic Micronutrients Lymphoma, Large-cell Leukemia, B-cell, Chronic Hodgkin Disease Lymphoma Lymphoma, Large B-Cell, Diffuse Vitamin B Complex Immunoproliferative Disorders Hodgkin Lymphoma, Adult Leukemia-Lymphoma, Adult T-Cell Immunoblastic Lymphadenopathy |
Antimetabolites Vitamin B Complex Neoplasms by Histologic Type Immunoproliferative Disorders Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Leucovorin Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Vitamins Therapeutic Uses Fluorouracil Micronutrients Lymphoproliferative Disorders Lymphoma |