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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005825
Recruitment Status : Unknown
Verified July 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: mitomycin C Drug: tretinoin Drug: vinorelbine tartrate Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Trans Retinoic Acid (Vesanoid) With Chemotherapy in Non-Small Cell Lung Cancer
Study Start Date : September 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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



  • Over 18

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified


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


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


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


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


  • 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


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


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


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005825

United States, California
Rajendra Prasad M.D., Inc.
Lakewood, California, United States, 90712
Sponsors and Collaborators
Raghu Nandan, M.D., Inc
Study Chair: Raghu Nandan, MD Raghu Nandan, M.D., Inc Identifier: NCT00005825     History of Changes
Other Study ID Numbers: CDR0000067837
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: July 2003

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antibiotics, Antineoplastic
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Keratolytic Agents
Dermatologic Agents