Chemotherapy Given With Amifostine and Filgrastim in Treating Patients With Recurrent or Metastatic Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia; Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: amifostine trihydrate (Drug); carboplatin (Drug); filgrastim (Drug); paclitaxel (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Roswell Park Cancer Institute Official(s) and/or principal investigator(s):
Gary N. Schwartz, MD, Study Chair, Affiliation: Norris Cotton Cancer Center
Summary
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.
Clinical Details
Official title: Initial Clinical Evaluation of the Combination of Paclitaxel and Carboplatin With Modulation of Toxicity With GCSF and Amifostine
Study design: Treatment
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: May 1997
Last updated: May 23, 2008
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