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Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Study NCT00005825   Information provided by National Cancer Institute (NCI)
First Received: June 2, 2000   Last Updated: July 23, 2008   History of Changes

June 2, 2000
July 23, 2008
September 1998
 
 
 
Complete list of historical versions of study NCT00005825 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Trans Retinoic Acid (Vesanoid) With Chemotherapy in Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

OBJECTIVES:

  • Determine the response rate and duration of response to mitomycin, vinorelbine, and cisplatin plus tretinoin in patients with stage IIIB or IV non-small cell lung cancer.
  • Determine the toxicity of this treatment regimen in these patients.
  • Determine survival of these patients with this treatment regimen.

OUTLINE: Patients receive tretinoin orally twice daily for 4 days starting days 1 and 8; cisplatin IV over 2 hours and vinorelbine IV on days 1 and 8; and mitomycin IV (courses 1 and 3) on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: At total of 15-46 patients will be accrued for this study.

Phase II
Interventional
Treatment
Lung Cancer
  • Drug: cisplatin
  • Drug: mitomycin C
  • Drug: tretinoin
  • Drug: vinorelbine ditartrate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IIIB or IV non-small cell lung cancer
  • Measurable disease
  • No brain metastases

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 2 times upper limit of normal (ULN)
  • AST and ALT less than 2.5 times ULN (unless attributed to liver metastases)

Renal:

  • Creatinine no greater than 1.5 mg/dL AND/OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No myocardial infarction within past 6 months
  • No congestive heart failure
  • No uncontrolled arrhythmia

Other:

  • No other concurrent or prior malignancy within past 5 years except localized basal cell or squamous cell skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy with clearly progressive disease
  • Concurrent palliative radiotherapy allowed if no evidence of disease progression

Surgery:

  • Not specified
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005825
 
CDR0000067837, NANDAN-VES-024, NCI-V00-1587
Raghu Nandan, M.D., Inc
 
Study Chair: Raghu Nandan, MD Raghu Nandan, M.D., Inc
National Cancer Institute (NCI)
July 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP