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Combination Chemotherapy in Treating Patients With Advanced Cancer

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00003331

First Posted: September 13, 2004

Last Update Posted: March 28, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Cancer Institute (NCI)

Information provided by:

New York University School of Medicine

Purpose

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	Intervention	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


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple myeloma

Drug Information available for: Fluorouracil Topotecan hydrochloride Topotecan

Genetic and Rare Diseases Information Center resources: Diffuse Large B-Cell Lymphoma Lymphosarcoma Multiple Myeloma Myelodysplastic Syndromes Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myeloid Leukemia Myelofibrosis Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Polycythemia Vera Chronic Myeloproliferative Disorders Essential Thrombocythemia Burkitt Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Marginal Zone Lymphoma B-cell Lymphoma Mantle Cell Lymphoma Follicular Lymphoma Waldenstrom Macroglobulinemia Lymphoma, Large-cell Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Leukemia, T-cell, Chronic Adult T-cell Leukemia/lymphoma Hodgkin Lymphoma Primary Central Nervous System Lymphoma AL Amyloidosis Large Granular Lymphocyte Leukemia Aggressive NK Cell Leukemia Monoclonal Gammopathy of Undetermined Significance Anaplastic Large Cell Lymphoma Anaplastic Plasmacytoma Lymphoblastic Lymphoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Hairy Cell Leukemia

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:


Estimated Enrollment:	30
Study Start Date:	January 1998
Primary Completion Date:	November 2001 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


United States, New York
Kaplan Cancer Center
New York, New York, United States, 10016

Sponsors and Collaborators

New York University School of Medicine

National Cancer Institute (NCI)

Investigators


Study Chair:	Howard S. Hochster, MD	New York University School of Medicine

More Information


ClinicalTrials.gov Identifier:	NCT00003331 History of Changes
Other Study ID Numbers:	CDR0000066292 P30CA016087 ( U.S. NIH Grant/Contract ) NYU-9752 NCI-G98-1421
First Submitted:	November 1, 1999
First Posted:	September 13, 2004
Last Update Posted:	March 28, 2011
Last Verified:	March 2011

Keywords provided by New York University School of Medicine:


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

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

Additional relevant MeSH terms:


Lymphoma Syndrome Leukemia Multiple Myeloma Neoplasms, Plasma Cell Myelodysplastic Syndromes Preleukemia Plasmacytoma Myeloproliferative Disorders Precancerous Conditions 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 Fluorouracil Topotecan Levoleucovorin Antimetabolites

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