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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2003 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on June 2, 2000. Last Updated on February 26, 2011 History of Changes

Sponsor:	Raghu Nandan, M.D., Inc
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 tartrate	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

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

U.S. FDA Resources

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

Raghu Nandan, M.D., Inc

Investigators

Study Chair:

Raghu Nandan, MD

Raghu Nandan, M.D., Inc

More Information

Additional Information:

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00005825 History of Changes
Other Study ID Numbers:	CDR0000067837, NANDAN-VES-024, NCI-V00-1587
Study First Received:	June 2, 2000
Last Updated:	February 26, 2011
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

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Mitomycins
Mitomycin
Vinorelbine
Cisplatin
Tretinoin

Vinblastine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Keratolytic Agents
Dermatologic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators

ClinicalTrials.gov processed this record on February 09, 2012