Mequinol/Tretinoin Topical |
mequinol and tretinoin; Solage |
Clinical Trial: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
This study is no longer recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer | Drug: cisplatin Drug: mitomycin Drug: tretinoin Drug: vinorelbine Procedure: chemotherapy | Phase II |
MedlinePlus related topics: Lung Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Mitomycin, Vinorelbine, and Cisplatin Plus Tretinoin in Patients With Stage IIIB or IV 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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location Information
California
Rajendra Prasad M.D., Inc., Lakewood, California, 90712, United States
Raghu Nandan, MD, Study Chair, Rajendra Prasad M.D., Inc.
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: September 2003
Last Updated: October 13, 2004
Record first received: June 2, 2000
ClinicalTrials.gov Identifier: NCT00005825
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Mequinol/Tretinoin Topical (Drug Digest)
- Solage (Drug Digest)

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