Combination Chemotherapy in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00003331
First received: November 1, 1999
Last updated: March 25, 2011
Last verified: March 2011
  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:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Chair: Howard S. Hochster, MD New York University School of Medicine
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003331     History of Changes
Other Study ID Numbers: CDR0000066292, P30CA016087, NYU-9752, NCI-G98-1421
Study First Received: November 1, 1999
Last Updated: March 25, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Neoplasms
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Precancerous Conditions
Lymphoma, Large-Cell, Immunoblastic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Fluorouracil
Topotecan
Leucovorin
Levoleucovorin
Antimetabolites

ClinicalTrials.gov processed this record on July 24, 2014