VX-710, Doxorubicin, and Vincristine in Treating Patients With Recurrent Small Cell Lung Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: biricodar dicitrate (Drug); doxorubicin hydrochloride (Drug); vincristine (Drug); chemotherapy (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Vertex Pharmaceuticals Incorporated Official(s) and/or principal investigator(s):
Matthew Harding, PhD, Study Chair, Affiliation: Vertex Pharmaceuticals 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 recurrent small cell lung cancer following treatment.
Clinical Details
Official title: A Phase II Study of the Safety, Efficacy and Pharmacokinetics of VX-710 in Combination With Doxorubicin and Vincristine in Patients With Small Cell Lung Cancer (SCLC)
Study design: Treatment
Detailed description:
OBJECTIVES: I. Establish the safety of VX-710 in combination with doxorubicin and vincristine
in patients with recurrent small cell lung cancer. II. Characterize the plasma
pharmacokinetics of this regimen in these patients. III. Establish the ability of this
regimen to improve the response rate to chemotherapy in these patients who have relapsed on
front line therapy. IV. Evaluate the multidrug resistance profile of these patients in
response to this regimen.
OUTLINE: This is a multicenter study. Stage I: Patients receive VX-710 IV over 72 hours,
followed by doxorubicin IV and vincristine IV four hours after initial VX-710. Vincristine is
administered at half dose in the first 3-6 patients. If no more than 1 of 6 patients
experiences dose limiting toxicity in the half dose cohort, 3 additional patients receive
full dose vincristine. The maximum tolerated dose is defined as the dose preceeding that at
which 2 of 6 patients experience dose limiting toxicity. Stage II: Patients receive VX-710 IV
over 72 hours, followed by doxorubicin IV and full dose vincristine IV four hours after
initial VX-710. Treatment continues for up to 6 courses every 3 weeks in the absence of
disease progression or unacceptable toxicity. Patients are followed every 3 months for up to
1 year.
PROJECTED ACCRUAL: A minimum of 35 and a maximum of 92 patients will be accrued for this
study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 first 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, trolandeomycin, sulfinpyrazone, rifampin,
Dilantin, and cyclosporine-A (or other P-gp inhibitors)
Locations and Contacts
University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States
Indiana University Cancer Center, Indianapolis, Indiana 46202-5265, United States
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Fallon Clinic Inc., Worcester, Massachusetts 01605, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, United States
St. John's Mercy Medical Center, Saint Louis, Missouri 63141, United States
Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States
Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 1998
Last updated: March 1, 2008
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