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VX-710, Doxorubicin, and Vincristine in Treating Patients With Recurrent Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: August 23, 2008   History of Changes
Sponsored by: Vertex Pharmaceuticals Incorporated
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003847
  Purpose

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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 92
Study Start Date: December 1998
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003847

Locations
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
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Chair: Matthew Harding, PhD Vertex Pharmaceuticals Incorporated
  More Information

Additional Information:
Publications:
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

Keywords provided by National Cancer Institute (NCI):
recurrent small cell lung cancer
intermediate type small cell lung cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 02, 2009