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Combination Chemotherapy With or Without Biological Therapy in Treating Patients With Refractory Solid Tumor or Lymphoma
This study has been completed.
First Received: April 6, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Fox Chase Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005021
  Purpose

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, giving the drugs in different ways, and combining biological therapy with chemotherapy may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of topotecan, paclitaxel, and carboplatin with or without filgrastim in treating patients who have advanced solid tumor or lymphoma that has not responded to standard therapy.


Condition Intervention Phase
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Biological: filgrastim
Drug: carboplatin
Drug: paclitaxel
Drug: topotecan hydrochloride
Phase I

MedlinePlus related topics: Cancer Fungal Infections Hodgkin's Disease Intestinal Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
Drug Information available for: Paclitaxel Carboplatin Topotecan hydrochloride Filgrastim Topotecan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: PHASE I EVALUATION OF TOPOTECAN IN COMBINATION WITH PACLITAXEL AND CARBOPLATIN

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 1996
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated doses of combined topotecan, paclitaxel, and carboplatin (TOPO/TAX/CBDCA) with or without filgrastim (G-CSF) in patients with advanced solid tumors or lymphomas. II. Determine the toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of TOPO/TAX/CBDCA and whether TAX/CBDCA will affect the pharmacokinetics of TOPO on day 1 as compared to TOPO administered alone on day 3. IV. Describe any clinical responses observed in these patients.

OUTLINE: This is a dose escalation study of the combination topotecan/paclitaxel/carboplatin. Patients are stratified according to prior chemotherapy and radiotherapy (yes vs no). Part I: Patients receive topotecan IV on days 1-3 and paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes, on day

1. Part II: Patients receive topotecan, paclitaxel, and carboplatin as in part I, plus filgrastim (G-CSF) on days 6-19. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of topotecan/paclitaxel/carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study within 4 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven advanced solid tumor or lymphoma that is refractory to standard therapy or for which no standard therapy exists or for which the drugs used in this regimen constitute standard therapy Brain metastasis eligible provided: Evidence of neurologic improvement or normalization No evidence of radiographic progression after appropriate therapy Steroid dose stable (if given)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: Greater than 3 months Hematopoietic: Absolute granulocyte count at least 2,000/mm2 Platelet count at least 100,000/mm2 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases less than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction within 6 months No history of congestive heart failure No uncontrolled angina No uncontrolled arrhythmia Other: No concurrent medical illness or active infection that would render treatment unsafe Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior topotecan, paclitaxel, and carboplatin allowed if progression observed greater than 3 months after last dose No prior mitomycin or nitrosoureas No more than 1 prior chemotherapy regimen At least 4 weeks since chemotherapy and recovered (alopecia allowed) Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 25% of bone marrow At least 4 weeks since radiotherapy and recovered (alopecia allowed) Surgery: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005021

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Study Chair: Corey J. Langer, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000064913, FCCC-96004, NCI-T95-0075H
Study First Received: April 6, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00005021     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
small intestine lymphoma
unspecified adult solid tumor, protocol specific
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
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

Study placed in the following topic categories:
Lymphoma, Mantle-Cell
Mantle Cell Lymphoma
Ileal Diseases
Follicular Lymphoma
Duodenal Neoplasms
Mycoses
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Digestive System Neoplasms
Carboplatin
B-cell Lymphomas
Paclitaxel
Leukemia, T-Cell
Gastrointestinal Neoplasms
Topotecan
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Phytogenic
Lymphoma, T-Cell, Cutaneous
Gastrointestinal Diseases
Lymphoma, Follicular
Central Nervous System Lymphoma, Primary
Lymphoma, B-Cell, Marginal Zone
Sezary Syndrome
Mycosis Fungoides
Lymphoblastic Lymphoma
Lymphoma, Large-cell, Immunoblastic
Lymphoma, B-Cell

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Ileal Diseases
Duodenal Neoplasms
Neoplasms by Site
Ileal Neoplasms
Jejunal Diseases
Therapeutic Uses
Lymphoma
Duodenal Diseases
Jejunal Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Digestive System Neoplasms
Immune System Diseases
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Intestinal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Lymphatic Diseases
Neoplasms
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Gastrointestinal Neoplasms
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 07, 2009