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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.
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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
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--
- Histologically confirmed non-small cell lung cancer (NSCLC); Locally advanced or metastatic disease
- Received a prior first-line taxane (as a single agent or component of a combination regimen) as the only chemotherapy for locally advanced or metastatic disease; Any amount of prior adjuvant chemotherapy allowed
- Bidimensionally measurable disease outside the field of prior radiotherapy; Amenable to radiologic imaging techniques
- No clinically apparent CNS metastases or carcinomatous meningitis
--Prior/Concurrent Therapy--
- Biologic therapy: No concurrent immunotherapy or therapeutic biologic response modifiers; No concurrent routine or prophylactic filgrastim (G-CSF) or sargramostim; No concurrent epoetin alfa
- Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered; No other concurrent cytotoxic chemotherapy
- Endocrine therapy: No concurrent hormonal therapy for NSCLC
- Radiotherapy: See Disease Characteristics; At least 2 weeks since prior limited-field radiotherapy not involving the hematopoietic bone marrow and recovered; At least 4 weeks since prior radiotherapy to no more than 25% of the hematopoietic bone marrow and recovered; No prior wide-field radiotherapy to the pelvis; No concurrent radiotherapy (including palliative radiotherapy)
- Surgery: At least 4 weeks since prior major surgery
- Other: At least 4 weeks since prior investigational agents; No concurrent anticonvulsants unless required for study drug-related toxicity; No concurrent high-dose acetaminophen (i.e., at least 4 g/day); No other concurrent investigational agents
--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
Sean McCarthy, Study Chair, Tularik
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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
Resources
- Small Businesses (Centers for Disease Control and Prevention)

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