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

NCT00022243 | Unknown Phase 2

• 3 other identifiers: CDR0000068798TULA-T2002VU-000511
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Interventions

batabulin sodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Tularik: lead

Study Sites (2)

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Publications (1)

• Jahan TM, Sandler A, Burris H, et al.: A phase II study of T138067-sodium in prior taxane-treated patients (pts) with locally advanced or metastatic non-small cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1282, 2002.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Sean McCarthy

  Tularik

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: February 4, 2004
• Study Start: October 1, 2000
• Last Updated: January 6, 2014

Record last verified: 2002-05

Locations

US (2)