ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: R. Nandan M.D. Incorporated
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005825
  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 Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: mitomycin C
Drug: tretinoin
Drug: vinorelbine ditartrate
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Cisplatin    Vinorelbine    Vinorelbine tartrate    Tretinoin    Mitomycin    Mitomycins   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Trans Retinoic Acid (Vesanoid) With Chemotherapy in Non-Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   September 1998

Detailed Description:

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005825

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

Sponsors and Collaborators
R. Nandan M.D. Incorporated

Investigators
Study Chair:     Raghu Nandan, MD     R. Nandan M.D. Incorporated    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067837, NANDAN-VES-024, NCI-V00-1587
First Received:   June 2, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005825
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Vinblastine
Mitomycins
Carcinoma
Vinorelbine
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Lung Diseases
Mitomycin
Tretinoin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Antibiotics, Antineoplastic
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Alkylating Agents
Antineoplastic Agents, Phytogenic
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers