Overview

VX-710, Doxorubicin, and Vincristine for the Treatment of Patients With Recurrent Small Cell Lung Cancer

Status:
Terminated
Trial end date:
1969-12-31
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 II trial to study the effectiveness of combination chemotherapy for the treatment of patients who have recurrent small cell lung cancer following treatment.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Treatments:
Doxorubicin
Liposomal doxorubicin
Vincristine
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed oat cell or intermediate type small cell
lung cancer Patients must have received prior therapy, with the following: Documented
disease progression (new lesions or increased lesion size) after front line therapy No more
than 1 prior chemotherapy regimen Complete or partial response to initial chemotherapy
(must have lasted more than 60 days after end of therapy before relapse occurred)
Bidimensionally measurable disease At least one lesion outside of irradiation field Pleural
effusions are not measurable No brain or bone metastases as only measurable site No
uncontrolled brain or other CNS metastases (surgical excision and/or radiotherapy)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: AST no greater than 2 times upper limit of normal Bilirubin no
greater than 1.5 mg/dL Renal: Creatinine less than 1.3 mg/dL OR Creatinine clearance
greater than 60 mL/min Cardiovascular: Cardiac ejection fraction greater than 45% by MUGA
or echocardiogram No uncontrolled ventricular arrhythmias Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception No senile
dementia or psychiatric disorders Not concurrent serious infection No major seizure
disorder No grade 3 neuropathies No spinal cord compression No other concurrent unstable
medical condition No other prior malignancies within past 5 years, except: Adequately
treated basal or squamous cell skin cancer Any carcinoma in situ

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No prior doxorubicin or vincristine as first line treatment for small cell
lung cancer Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to greater
than 50% of bone marrow At least 30 days since prior radiotherapy Surgery: Not specified
Other: No concurrent experimental drugs or anticancer therapies Concurrent medication for
chronic medical conditions allowed (e.g., hypertension) No concurrent cimetidine,
phenothiazines, phenobarbital, carbamazepine, troleandomycin, sulfinpyrazone, rifampin,
Dilantin, and cyclosporine-A (or other P-gp inhibitors)