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T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy - Article


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Clinical Trial: T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy

This study is no longer recruiting patients.

Sponsored by: Tularik
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. PURPOSE: Phase II trial to study the effectiveness of T138067 in treating patients who have locally advanced or metastatic non-small cell lung cancer that has not responded to previous chemotherapy.

Condition Treatment or Intervention Phase
stage IIIA non-small cell lung cancer
stage IV non-small cell lung cancer
stage IIIB non-small cell lung cancer
recurrent non-small cell lung cancer
 Procedure: chemotherapy
 Drug: T138067 sodium
Phase II

MedlinePlus related topics:  Lung Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of T138067 Sodium in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed First-Line Therapy With a Taxane

Further Study Details: 

Study start: October 2000

OBJECTIVES: I. Determine the objective tumor response rate in patients with locally advanced or metastatic non-small cell lung cancer who have failed first-line therapy with a taxane when treated with T138067 sodium. II. Determine the qualitative and quantitative toxic effects of this drug in these patients. III. Determine the number of patients who progress when treated with this drug. IV. Determine the duration of response, time to disease progression, and median survival of patients treated with this drug. V. Correlate the toxic effects of this drug with peak plasma levels in this patient population.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive T138067 sodium IV over 3 hours on days 1, 8, and 15. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months after study completion.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 9 months.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: Karnofsky 70-100%
  • Life expectancy: At least 12 weeks
  • Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
  • Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); AST and ALT no greater than 3 times ULN; Albumin greater than 2.5 g/dL; No history of Gilbert's syndrome
  • Renal: Creatinine no greater than 1.5 times ULN
  • Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix; No other severe disease, infection, or comorbidity that would preclude study participation; No known defect of glutathione metabolism; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 months after study

Location Information


California
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94143-0128,  United States

Tennessee
      Vanderbilt-Ingram Cancer Center, Nashville,  Tennessee,  37232-6838,  United States

Study chairs or principal investigators

Sean McCarthy,  Study Chair,  Tularik   

More Information

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

Study ID Numbers:  CDR0000068798; TULA-T2002; VU-000511
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022243
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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

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Page Updated: November 22, 2004
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