Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI MDA-DM-90101 NCI-T90-0226C, T90-0226

Objectives

I.  Determine the efficacy of deoxyspergualin (DSG) given by continuous 
intravenous infusion for 5 days every 3 weeks to patients with extensive small 
cell lung cancer.
II.  Determine the qualitative and quantitative toxicities of DSG given on 
this schedule.
III.  Evaluate the response to cisplatin/etoposide used as a salvage regimen, 
and measure the survival of patients treated on these regimens.

Entry Criteria

Disease Characteristics:

Histologically or cytologically documented extensive stage
small cell lung cancer

Disease spread beyond ipsilateral lung or regional lymph
nodes covered by a single radiation port

Measurable or evaluable disease required

No brain metastases

Prior/Concurrent Therapy:

Biologic therapy:
  No prior or concurrent immunotherapy

Chemotherapy:
  No prior or concurrent chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior or concurrent radiotherapy

Surgery:
  Not specified

Other:
  No concurrent monoamine oxidase inhibitors (e.g.,
  phenelzine, tranylcypromine)

Patient Characteristics:

Age:
  18 and over

Performance status:
  Zubrod 0 or 1

Life expectancy:
  At least 12 weeks

Hematopoietic:
  AGC at least 1,800
  Platelets greater than 150,000

Hepatic:
  Bilirubin no greater than 1.5 mg/dl
  SGPT no greater than 1.5 x ULN

Renal:
  Creatinine no greater than 1.5 mg/dl
  Creatinine clearance at least 60 ml/min

Cardiovascular:
  No myocardial infarction within 6 months
  No CHF
  No symptomatic coronary heart disease
  No cerebrovascular disease

Other:
  Adequate contraception required of fertile patients

Expected Enrollment

Initially, 9 evaluable patients will be entered.  If at least one partial or 
complete response is observed, an additional 21 patients will be accrued.  It 
is anticipated that the study will be completed in 30 months.

Outline

Nonrandomized study.  Patients are initially treated on Regimen A, then 
proceed to Regimen B when disease is stable or progressing.
Regimen A:  Single-agent Chemotherapy.  Deoxyspergualin, DSG, NSC-356894.
Regimen B:  2-Drug Combination Chemotherapy.  Cisplatin, CDDP, NSC-119875; 
Etoposide, VP-16, NSC-141540.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Dong Shin, MD, Protocol chair(Contact information may not be current)		Ph: 412-235-1021