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	Treatment	Completed	any age	NCI	NCCTG-892051 MAYO-892051, NCCTG-89-20-51

Objectives

I.  Compare response rates, time to progression, and survival of extensive 
stage small cell lung cancer patients treated with etoposide/cisplatin who are 
randomly allocated to receive additionally megestrol vs. placebo.

II.  Define megestrol-related toxicities in these patients.

III.  Evaluate appetite, weight changes, and perceived quality of life in 
these 2 treatment groups.

IV.  Assess the effect of megestrol on nausea and vomiting in these patients.

Entry Criteria

Disease Characteristics:

Histologically or cytologically documented small cell lung
cancer

Extensive disease required, defined as 1 or more of the
following:

  Metastatic disease outside the chest

  Disease inside the chest that would require a hemithorax or
  otherwise intolerable radiotherapy port

  Involvement of the contralateral supraclavicular nodes

Measurable or evaluable disease required

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy

Surgery:
  At least 14 days since major surgery

Patient Characteristics:

Age:
  Any age

Performance status:
  ECOG 0-2

Hematopoietic:
  WBC at least 3,500
  Platelets at least 100,000
  Hb at least 9.5 g/dl

Hepatic:
  Bilirubin normal
  SGOT no more than 5 x ULN
  Alkaline phosphatase no more than 5 x ULN

Renal:
  Creatinine no greater than 1.5 x ULN

Cardiovascular:
  No MI within 3 months of entry
  No history of CHF

Other:
  No persistent (daily) vomiting
  No uncontrolled infection
  No second malignancy within 3 years except:
     Nonmelanomatous skin cancer
     In situ cervical cancer
  No pregnant or nursing women

Expected Enrollment

Accrual of the 250 patients required should be complete in 2-2.5 years.

Outline

Randomized, double-blind study.

Arm I:  2-Drug Combination Chemotherapy plus Anticachectic Therapy followed by 
Radiotherapy.  EP:  Etoposide, VP-16, NSC-141540; Cisplatin, CDDP, NSC-119875; 
plus Megestrol, MEG, NSC-71423; followed, as indicated, by thoracic 
irradiation and cranial irradiation using Co6O equipment or photons with 4-10 
MeV energies.

Arm II:  2-Drug Combination Chemotherapy plus Placebo Therapy followed by 
Radiotherapy.  VP-16; CDDP; plus Placebo; followed by radiotherapy as on Arm I.

Rowland KM Jr, Loprinzi CL, Shaw EG, et al.: Randomized double-blind placebo-controlled trial of cisplatin and etoposide plus megestrol acetate/placebo in extensive-stage small-cell lung cancer: a North Central Cancer Treatment Group study. J Clin Oncol 14 (1): 135-41, 1996.[PUBMED Abstract]

Rowland KM, Jett JR, Jung SH, et al.: Phase III randomized double blind placebo controlled trial of cisplatin (P) and etoposide (E) plus megestrol acetate (M)/placebo in extensive small cell lung (SCLC): a North Central Cancer Treatment Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-1092, 330, 1994.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Kendrith Rowland, MD, Protocol chair		Ph: 217-383-3019 Email: kendrith.rowland@carle.com

Mayo Clinic Cancer Center

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