Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: cisplatin (Drug); mitomycin C (Drug); tretinoin (Drug); vinorelbine ditartrate (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: R. Nandan M.D. Incorporated Official(s) and/or principal investigator(s):
Raghu Nandan, MD, Study Chair, Affiliation: R. Nandan M.D. Incorporated
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.
Clinical Details
Official title: Trans Retinoic Acid (Vesanoid) With Chemotherapy in Non-Small Cell Lung Cancer
Study design: Treatment
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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
Locations and Contacts
Rajendra Prasad M.D., Inc., Lakewood, California 90712, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: September 1998
Last updated: May 23, 2008
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