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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over Pharmaceutical / Industry MSKCC-95088 RP-56976-TAX-320, NCI-V96-0830

Objectives

I.  Evaluate survival in patients who receive 100 or 75 milligrams per square 
meter of docetaxel vs. either ifosfamide (6 grams per square meter every 3 
weeks) or vinorelbine (30 milligrams per square meter per week) for non-small 
cell lung cancer previously treated with platinum-containing chemotherapy.

II.  Compare the quality of life of patients on all 3 regimens.

III.  Compare the safety, response rate, and duration of response in patients 
on the two docetaxel regimens.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed non-small cell lung cancer

Unresectable, locally advanced or metastatic disease that has progressed
during or after 1 platinum-based chemotherapy
  Platinum therapy administered as part of combined modality, adjuvant, or
  neoadjuvant chemotherapy

Measurable or evaluable indicator lesion required
  More than 30 days since irradiation of target lesion or radiation therapy to
  major bone marrow (greater than 10% of bone marrow) areas

No symptomatic or uncontrolled brain metastases

Prior/Concurrent Therapy:

More than 30 days since a clinical trial or experimental agent

Biologic therapy:
  More than 21 days since immunotherapy or biologic systemic anticancer
  therapy

Chemotherapy:
  See Disease Characteristics
  No prior docetaxel
  No prior combination ifosfamide/vinorelbine (either drug alone allowed)
  More than 21 days since chemotherapy (more than 42 days since mitomycin or
     nitrosourea)

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior irradiation of more than 10% of bone marrow
  At least 30 days since radiotherapy to target lesions

Surgery:
  Not specified

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0-2

Hematopoietic:
  ANC at least 2,000/mm3
  Platelet count at least 100,000/mm3

Hepatic:
  Bilirubin no greater than normal
  AST/ALT no greater than 1.5 times normal
  Alkaline phosphatase no greater than 5 times normal

Renal:
  Creatinine no greater than 2.0 mg/dL OR
  Creatinine clearance no less than 60 mL/min

Other:
  No grade 3/4 peripheral neuropathy
  No serious intercurrent illness
  No psychological, familial, sociological, geographical, or other concurrent 
     condition that precludes compliance and follow-up
  No history of second malignancy that could relapse during study
  No pregnant or nursing women
     Negative pregnancy test required of fertile women
  Effective contraception required of fertile patients

Expected Enrollment

360 evaluable patients will be studied (20 patients/center).  Accrual will 
take 9 months.

Outline

Randomized study.  The following acronyms are used:
  IFF      Ifosfamide, NSC-109724
  Mesna    Mercaptoethane sulfonate, NSC-113891
  TXT      Docetaxel, NSC-628503
  VNB      Vinorelbine, NSC-608210

Arm I:  Single-Agent Chemotherapy.  TXT.  Low dose.

Arm II:  Single-Agent Chemotherapy.  TXT.  High dose.

Arm III:  Single-Agent Chemotherapy.  VNB or IFF/Mesna.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Vincent Miller, MD, Protocol chair		Ph: 212-639-7243; 800-525-2225 Email: millerv@mskcc.org