Clinical Trial: VX-710, Doxorubicin, and Vincristine in Treating Patients With Recurrent Small Cell Lung Cancer

This study is no longer recruiting patients.

Sponsored by: Vertex Pharmaceuticals
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
intermediate type small cell lung cancer
Recurrent Small Cell Lung Cancer
 Drug: doxorubicin
 Drug: vincristine
 Drug: VX-710
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lung Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of VX-710, Doxorubicin, and Vincristine in Patients with Recurrent Small Cell Lung Cancer

Further Study Details: 

Study start: 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.

PROTOCOL 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 above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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)

--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

Location Information


Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States

Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5265,  United States

Massachusetts
      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

Missouri
      St. John's Mercy Medical Center, Saint Louis,  Missouri,  63141,  United States

New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States

Study chairs or principal investigators

Matthew Harding,  Study Chair,  Vertex Pharmaceuticals   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067008; VX-98-710-006; NCI-V99-1537; DUMC-1450-98-9
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003847
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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