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Trans Retinoic Acid (Vesanoid) With Chemotherapy in Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Trans Retinoic Acid (Vesanoid) With Chemotherapy in Non-Small Cell Lung Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Raghu Nandan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Raghu Nandan, M.D., Inc

Authority:

United States: Federal Government

Study ID:

CDR0000067837

NCT ID:

NCT00005825

Start Date:

September 1998

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

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