ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Chemotherapy Given With Amifostine and Filgrastim in Treating Patients With Recurrent or Metastatic Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Roswell Park Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003294
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of paclitaxel plus carboplatin given with amifostine and filgrastim in treating patients with recurrent or metastatic cancer.


Condition Intervention Phase
Leukemia
Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Drug: amifostine trihydrate
Drug: carboplatin
Drug: filgrastim
Drug: paclitaxel
Phase I

MedlinePlus related topics:   Cancer    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma   

ChemIDplus related topics:   Carboplatin    Filgrastim    Paclitaxel    Granulocyte colony-stimulating factor    Amifostine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Initial Clinical Evaluation of the Combination of Paclitaxel and Carboplatin With Modulation of Toxicity With GCSF and Amifostine

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

Estimated Enrollment:   24
Study Start Date:   May 1997

Detailed Description:

OBJECTIVES: I. Establish the maximum tolerated dose of a paclitaxel and carboplatin combination modulated by amifostine and filgrastim (G-CSF) in patients with recurrent or metastatic cancer. II. Define the dose limiting toxicity of this combination in these patients. III. Observe any antitumor responses in patients treated with this combination.

OUTLINE: This is a dose escalation study of paclitaxel. Patients receive a 10 minute infusion of amifostine followed by paclitaxel given intravenously over 3 hours followed by carboplatin given over 30 minutes. Filgrastim (G-CSF) is given subcutaneously daily for up to 10 days by self administration starting the following day. Treatment repeats every 28 days for at least 3 courses unless disease progression or unacceptable toxicity occurs. Patients who develop dose-limiting toxicity (DLT) on a given course receive one dose level lower on the next and subsequent courses. Patients with stable disease may continue treatment for as long as benefit is shown. In the absence of DLT in the first 3 patients treated, subsequent cohorts of 3 patients each receive escalating doses of paclitaxel on the same schedule. If DLT occurs in 1 of 3 patients at a given dose level, then 3 additional patients are added at that dose. If DLT occurs in 1 additional patient, this dose is the maximum tolerated dose (MTD); if DLT occurs in more than 2 patients, then 3 additional patients are added at the previous dose. If DLT occurs in no more than 2 of 6 patients, this dose is considered the MTD. At any dose, 3 cases of DLT leads to discontinuation of recruitment at that dose.

PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study within 18 months.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically proven recurrent or metastatic malignant disease not amenable to curative surgery, radiotherapy, conventional chemotherapy, or investigational therapy of higher priority Priority given to patients with lung cancer or cancers with tumors easily available for biopsy No CNS disease unless stable post radiation

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 50 mL/min Cardiovascular: Systolic blood pressure at least 90 mm Hg No severe heart decompensation No clinically significant cardiac arrhythmia on EKG No inability to tolerate bradycardia Other: No active, uncontrolled infection No nonmalignant systemic disease Not pregnant or nursing Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immune stimulating agents Chemotherapy: At least 3 weeks since chemotherapy (6 weeks since nitrosourea or mitomycin) and recovered No prior paclitaxel or carboplatin No concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy Radiotherapy: At least 3 weeks since radiotherapy to major bone marrow bearing areas and recovered Concurrent radiotherapy allowed for vital indications or pain relief Surgery: At least 3 weeks since surgery

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003294

Locations
United States, New York
Roswell Park Cancer Institute    
      Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     Gary N. Schwartz, MD     Norris Cotton Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066227, RPCI-DS-97-14, NCI-G98-1410
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003294
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 chronic lymphocytic leukemia  
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
untreated hairy cell leukemia
progressive hairy cell leukemia, initial treatment
refractory hairy cell leukemia
chronic myelomonocytic leukemia
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

Study placed in the following topic categories:
Blast Crisis
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Lymphoma, Mantle-Cell
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Central nervous system lymphoma, primary
Leukemia, Prolymphocytic
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Acute myeloid leukemia, adult
Hodgkin Disease
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Leukemia, Myelomonocytic, Chronic
Leukemia, B-cell, chronic
Acute myelogenous leukemia
Carboplatin
Leukemia, Myeloid
Paclitaxel
Leukemia, Myeloid, Accelerated Phase
B-cell lymphomas
Leukemia, T-Cell
Anaplastic large cell lymphoma
Leukemia, B-Cell
Lymphoma, Non-Hodgkin
Hairy cell leukemia

Additional relevant MeSH terms:
Radiation-Protective Agents
Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Protective Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers