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Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer - Article


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Mequinol/Tretinoin Topical

mequinol and tretinoin; Solage 




Clinical Trial: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

This study is no longer recruiting patients.

Sponsored by: Rajendra Prasad M.D., Inc.
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
 Drug: cisplatin
 Drug: mitomycin
 Drug: tretinoin
 Drug: vinorelbine
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Lung Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Mitomycin, Vinorelbine, and Cisplatin Plus Tretinoin in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Location Information


California
      Rajendra Prasad M.D., Inc., Lakewood,  California,  90712,  United States

Study chairs or principal investigators

Raghu Nandan, MD,  Study Chair,  Rajendra Prasad M.D., Inc.   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067837; NANDAN-VES-024; NCI-V00-1587
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005825
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 24, 2009



Page Updated: September 6, 2005
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