Full Text View
Tabular View
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.
First Received: June 2, 2000   Last Updated: July 23, 2008   History of Changes
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: Mitomycin Cisplatin Vinorelbine Vinorelbine tartrate Tretinoin 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

Additional Information:
No publications provided

Study ID Numbers: CDR0000067837, NANDAN-VES-024, NCI-V00-1587
Study First Received: June 2, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005825     History of Changes
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
Vinblastine
Antimitotic Agents
Mitomycins
Carcinoma
Anti-Bacterial Agents
Vinorelbine
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Lung Diseases
Tubulin Modulators
Mitomycin
Non-small Cell Lung Cancer
Tretinoin
Antineoplastic Agents, Phytogenic
Alkylating Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Vinblastine
Antibiotics, Antineoplastic
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Mitomycin
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Vinorelbine
Lung Diseases
Tubulin Modulators
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009