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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Completed over 18 NCI NCCTG-892451 NCCTG-89-24-51

Objectives

I.  Determine whether administration of hydrazine sulfate (HDZ) increases 
survival in patients with advanced non-small cell lung cancer receiving 
cisplatin/etoposide chemotherapy.
II.  Evaluate whether HDZ administration results in improved appetite, 
non-fluid weight gain, and/or improved quality of life in patients with 
advanced, incurable lung cancer.
III.  Define the toxicity of HDZ in patients with advanced lung cancer.

Entry Criteria

Disease Characteristics:

Histologically or cytologically documented non-small cell lung
cancer not amenable to curative surgery or radiotherapy of 1 of
the following histologies:
  Large cell
  Squamous cell
  Adenocarcinoma
  Combinations of the above

No CNS metastases

Measurable, evaluable, or nonevaluable disease allowed

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy for lung cancer or any other cancer

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy to more than 15% of the functioning
  bone marrow within 30 days prior to entry

  No prior radiotherapy that would significantly compromise
  bone marrow function (i.e., the equivalent of 2,500 cGy
  marrow dose in 13 fractions to 30% or more of the bone
  marrow)

Surgery:
  At least 3 weeks since any major surgery

Other:
  No concurrent treatment with the following:
     Barbiturates or other tranquilizers (except as
        antiemetics)
     Alcohol
     Corticosteroids
     Androgens
     Progestational agents
     Other agents intended to stimulate appetite

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0-2

Life expectancy:
  At least 4 months

Hematopoietic:
  WBC at least 4,000
  Platelets at least 130,000
  Hb at least 10 g/dl

Hepatic:
  Bilirubin less than 3 x ULN
  SGOT less than 3 x ULN

Renal:
  Creatinine less than 1.5 x ULN

Other:
  No more than 10% weight loss during 3 months prior to entry
  No known GI obstruction
  No documented malabsorption
  Able to take oral medications reliably
  No insulin-requiring diabetes mellitus
  No severe infection
  No pregnant or nursing women

Expected Enrollment

220 patients will be entered over approximately 20 months.

Outline

Randomized study.
Arm I:  2-Drug Combination Chemotherapy plus Anticachectic Therapy.  
Etoposide, VP-16, NSC-141540; Cisplatin, CACP, NSC-119875; plus Hydrazine 
sulfate, HDZ, NSC-150014.
Arm II:  2-Drug Combination Chemotherapy plus Placebo Therapy.  VP-16; CACP; 
plus Placebo.

Loprinzi CL, Goldberg RM, Su JQ, et al.: Placebo-controlled trial of hydrazine sulfate in patients with newly diagnosed non-small-cell lung cancer. J Clin Oncol 12 (6): 1126-9, 1994.[PUBMED Abstract]

Loprinzi CL, Goldberg RG, Su JQ, et al.: Randomized double-blind, placebo-controlled trial evaluating hydrazine sulfate (HS) in patients with newly diagnosed non-small cell lung cancer: a North Central Cancer Treatment Group trial. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-1124, 337, 1993.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles Loprinzi, MD, Protocol chair		Ph: 507-284-8964 Email: cloprinzi@mayo.edu