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Sponsored by: |
Vertex Pharmaceuticals Incorporated |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003847 |
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.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: biricodar dicitrate Drug: doxorubicin hydrochloride Drug: vincristine sulfate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
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) |
Estimated Enrollment: | 92 |
Study Start Date: | December 1998 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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)
United States, Arkansas | |
University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 72205 | |
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202-5265 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Fallon Clinic Inc. | |
Worcester, Massachusetts, United States, 01605 | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
United States, Missouri | |
St. John's Mercy Medical Center | |
Saint Louis, Missouri, United States, 63141 | |
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 |
Study Chair: | Matthew Harding, PhD | Vertex Pharmaceuticals Incorporated |
Study ID Numbers: | CDR0000067008, VX-98-710-006, DUMC-1450-98-9, NCI-V99-1537 |
Study First Received: | November 1, 1999 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003847 History of Changes |
Health Authority: | United States: Federal Government |
recurrent small cell lung cancer intermediate type small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Vincristine Antimitotic Agents Doxorubicin Recurrence Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Anti-Bacterial Agents |
Neuroectodermal Tumors Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Tubulin Modulators Neuroepithelioma Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Neoplasms, Nerve Tissue Antibiotics, Antineoplastic Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Respiratory Tract Neoplasms Neoplasms by Histologic Type Mitosis Modulators |
Vincristine Antimitotic Agents Doxorubicin Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Lung Diseases Tubulin Modulators Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |