Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Supportive care, Treatment	Closed	Not specified	NCI	RPCI-DS-97-14 NCI-G98-1410, NCT00003294

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.

Entry 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

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

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

Expected Enrollment

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

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.
  

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Gary Schwartz, MD, Protocol chair		Ph: 603-653-6181; 800-639-6918 Email: gary.n.schwartz@hitchcock.org

Registry Information
Official Title		Initial Clinical Evaluation of the Combination of Paclitaxel and Carboplatin With Modulation of Toxicity With GCSF and Amifostine
Trial Start Date		1997-05-12
Registered in ClinicalTrials.gov		NCT00003294
Date Submitted to PDQ		1998-04-13
Information Last Verified		2000-06-01

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