Clinical trial NCT00005825: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Official title: Trans Retinoic Acid (Vesanoid) With Chemotherapy in Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Rajendra Prasad M.D., Inc.
state: California
Study officials:
affiliation: Raghu Nandan, M.D., Inc
name: Raghu Nandan, MD
role: STUDY_CHAIR
References: