Overview

Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer

Status:
Completed

Trial end date:
2002-03-01

Target enrollment:
0

Participant gender:
All

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 I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced non-small cell lung cancer.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Memorial Sloan Kettering Cancer Center

Collaborator:

National Cancer Institute (NCI)

Treatments:

Albumin-Bound Paclitaxel
Carboplatin
Gefitinib
Paclitaxel

Criteria

DISEASE CHARACTERISTICS: Histologically and/or cytologically confirmed advanced or
metastatic non-small cell lung cancer considered incurable with standard surgery or
irradiation No active brain metastases as indicated by clinical symptoms, cerebral edema,
and/or progressive growth

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 that has not worsened
within the past 7 days Life expectancy: At least 12 weeks Hematopoietic: Neutrophil count
at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than
1.25 times upper limit of normal (ULN) ALT/AST no greater than 2.5 times ULN (5 times ULN
if liver metastases) Renal: Creatinine no greater than 1.25 times ULN No greater than a
trace of blood or protein on urine labstix test Cardiovascular: No prior history of
clinically significant cardiac dysrhythmia, first degree heart block, or other severe
cardiac disease Opthalmologic: No potentially visually threatening epithelial abnormality
of the cornea other than scars, congenital abnormality, or corneal tear film (e.g.,
neurotrophic keratitis, corneal edema, or recurrent erosions) No signs and symptoms of
keratoconjunctivitis sicca No concurrent use of contact lenses Other: Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception No other
malignancies within the past 5 years except basal cell carcinoma or carcinoma in situ of
the cervix No evidence of severe or uncontrolled systemic diseases (e.g., hepatitis B,
hepatitis C, or HIV) No known chronic conditions No active dermatoses involving the face No
evidence of any other significant clinical disorder or laboratory finding that would
preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for non-small cell
lung cancer No concurrent biologic response modifiers Concurrent filgrastim (G-CSF) allowed
only for persistent neutropenia despite dose reductions in prior course Chemotherapy: No
prior chemotherapy for non-small cell lung cancer Endocrine therapy: No concurrent hormonal
therapy No concurrent tamoxifen Radiotherapy: See Disease Characteristics At least 2 weeks
since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics
Recovered from prior oncologic or other major surgery Other: No other concurrent anticancer
therapy No other concurrent investigational agents No concurrent drugs with known
significant 3A4 inhibitory effects (i.e., ketoconazole, itraconazole, troleandomycin,
erythromycin, diltiazem, verapamil) No concurrent hydroxychloroquine, amiodarone, or
chlorpromazine No concurrent topical eye medication