Full Text View
Tabular View
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.
Study NCT00003294   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
May 1997
 
 
 
Complete list of historical versions of study NCT00003294 on ClinicalTrials.gov Archive Site
 
 
 
Chemotherapy Given With Amifostine and Filgrastim in Treating Patients With Recurrent or Metastatic Cancer
Initial Clinical Evaluation of the Combination of Paclitaxel and Carboplatin With Modulation of Toxicity With GCSF and Amifostine

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.

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.

Phase I
Interventional
Treatment
  • Leukemia
  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Biological: filgrastim
  • Drug: amifostine trihydrate
  • Drug: carboplatin
  • Drug: paclitaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
24
 
 

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

Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003294
 
CDR0000066227, RPCI-DS-97-14, NCI-G98-1410
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Study Chair: Gary N. Schwartz, MD Norris Cotton Cancer Center
National Cancer Institute (NCI)
June 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP