Combination Chemotherapy in Treating Patients With Advanced Cancer
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| ClinicalTrials.gov Identifier: NCT00003331 |
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Recruitment Status :
Completed
First Posted : September 13, 2004
Last Update Posted : March 28, 2011
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining topotecan, fluorouracil, and leucovorin in treating patients who have advanced cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific | Drug: fluorouracil Drug: leucovorin calcium Drug: topotecan hydrochloride | Phase 1 |
OBJECTIVES: I. Evaluate the maximum tolerated dose (MTD) of continuous infusion topotecan in combination with fluorouracil for patients with advanced malignancy and establish a recommended phase II dose based on the MTD. II. Evaluate the dose limiting toxicity of this combination in these patients. II. Obtain pharmacokinetic and pharmacodynamic data for topoisomerase-1 depletion in patients receiving this treatment. IV. Identify any objective tumor responses arising from this treatment in these patients.
OUTLINE: This is a dose-escalation study of topotecan in combination with fluorouracil. Patients receive topotecan as a 24-hour continuous infusion on days 1-14 in combination with fluorouracil IV and leucovorin calcium IV on days 1-5; course repeats every 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. In the absence of dose limiting toxicity (DLT) in the first cohort of 3 patients treated, subsequent cohorts each receive escalating doses on the same schedule. If DLT is observed in 2 of 3 patients or 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose.
PROJECTED ACCRUAL: Approximately 6-30 patients will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I Study of Low Dose Continuous Infusion Topotecan in Combination With 5-Fluorouracil and Leucovorin for Advanced Malignancies |
| Study Start Date : | January 1998 |
| Actual Primary Completion Date : | November 2001 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven advanced malignancy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL SGOT less than 3 times upper limit of normal (ULN) (less than 5 times ULN if due to hepatic metastases) LDH less than 3 times ULN (less than 5 times ULN if due to hepatic metastases) Alkaline phosphatase less than 3 times ULN (less than 5 times ULN if due to hepatic metastases) Renal: Creatinine no greater than 1.5 mg/dL Other: No active infection requiring systemic therapy within 1 week prior to entry No significant concurrent illness No history of bleeding disorder or clotting factor deficiency No dementia or altered mental status that would prohibit informed consent Not pregnant or nursing Effective contraception strongly advised for fertile women
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors during topotecan infusion Chemotherapy: At least 3 weeks since prior chemotherapy No more than 3 prior chemotherapy regimens Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003331
| United States, New York | |
| Kaplan Cancer Center | |
| New York, New York, United States, 10016 | |
| Study Chair: | Howard S. Hochster, MD | NYU Langone Health |
| ClinicalTrials.gov Identifier: | NCT00003331 |
| Other Study ID Numbers: |
CDR0000066292 P30CA016087 ( U.S. NIH Grant/Contract ) NYU-9752 NCI-G98-1421 |
| First Posted: | September 13, 2004 Key Record Dates |
| Last Update Posted: | March 28, 2011 |
| Last Verified: | March 2011 |
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stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma monoclonal gammopathy of undetermined significance recurrent adult Hodgkin lymphoma isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma Waldenstrom macroglobulinemia stage III multiple myeloma stage IV chronic lymphocytic leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia unspecified adult solid tumor, protocol specific |
chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission polycythemia vera primary myelofibrosis essential thrombocythemia untreated hairy cell leukemia progressive hairy cell leukemia, initial treatment refractory hairy cell leukemia chronic myelomonocytic leukemia |
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Lymphoma Leukemia Multiple Myeloma Neoplasms, Plasma Cell Preleukemia Precancerous Conditions Myelodysplastic Syndromes Myeloproliferative Disorders Syndrome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Disease Pathologic Processes Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Leucovorin Fluorouracil Topotecan Calcium Levoleucovorin |