Chemotherapy Given With Amifostine and Filgrastim in Treating Patients With Recurrent or Metastatic Cancer

Lymphoma Clinical Trial

Official title:

Initial Clinical Evaluation of the Combination of Paclitaxel and Carboplatin With Modulation of Toxicity With GCSF and Amifostine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003294
• Other study ID #: CDR0000066227
• Secondary ID: P30CA016056RPCI-
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: March 3, 2011
• Start date: May 1997
• Est. completion date: May 2004

Study information

• Verified date: March 2011
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2004
• Est. primary completion date: April 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Biological:
• filgrastim

Drug:
• amifostine trihydrate

• carboplatin

• paclitaxel

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,