Patient Abstract available in the near future.

Condition	Treatment or Intervention	Phase
stage IV non-small cell lung cancer Adenosquamous Cell Lung Cancer Squamous Cell Lung Cancer Bronchoalveolar Cell Lung Cancer stage IIIB non-small cell lung cancer recurrent non-small cell lung cancer Adenocarcinoma of the Lung large cell lung cancer	Procedure: chemotherapy  Drug: TLK286	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the 12-month survival of patients with advanced non-small cell lung cancer treated with TLK286. II. Determine the overall survival of patients treated with this drug. III. Determine the objective response rate, duration of objective response, time to tumor progression, and disease stabilization in patients treated with this drug. IV. Determine the safety of this drug in these patients.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive TLK286 IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for 1 year and then every 12 weeks thereafter.

PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study within 12 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed non-small cell lung cancer (NSCLC), including: Squamous cell carcinoma; Undifferentiated carcinoma; Adenocarcinoma; Mixed (i.e., adenocarcinoma with squamous cell carcinoma); No mixed tumors containing small cell lung carcinoma elements; Bronchoalveolar carcinoma; Large cell carcinoma
• Bronchoalveolar lavage allowed for diagnosis
• Advanced or metastatic NSCLC Stage IIIB disease ineligible for combined chemotherapy and radiotherapy OR Stage IV disease
• Progressive NSCLC during or after first-line therapies with platinum-containing chemotherapy regimens in the advanced or metastatic setting
• Measurable disease by radiological imaging techniques
• Previously treated CNS metastases allowed provided: Neurologically stable; Oral or IV steroids or anticonvulsants not required; No active disease by CT scan or MRI
• No known leptomeningeal metastases or carcinomatous meningitis

--Prior/Concurrent Therapy--

• Biologic therapy: At least 4 weeks since prior immunotherapy; At least 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF); No concurrent immunotherapy; No concurrent biological response modifiers
• Chemotherapy: See Disease Characteristics; No more than 2 prior cytotoxic regimens in the advanced or metastatic setting; At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin); No other concurrent chemotherapy
• Endocrine therapy: See Disease Characteristics
• Radiotherapy: At least 4 weeks since prior radiotherapy; At least 4 weeks since prior radiopharmaceuticals; At least 2 weeks since prior palliative radiotherapy; No concurrent radiotherapy except local radiotherapy for pain or solitary brain metastasis if not progressing systemically
• Surgery: At least 4 weeks since prior major surgery
• Other: Recovered from prior therapy; Prior adjuvant therapy allowed; At least 30 days since prior investigational drugs; No other concurrent investigational agents

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-1
• Life expectancy: At least 12 weeks
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.0 g/dL
• Hepatic: Bilirubin no greater than 2.0 mg/dL; ALT and AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
• Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min; No gross hematuria
• Cardiovascular: No uncontrolled cardiac arrhythmia; No myocardial infarction within the past 6 months
• Other: No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer; No severe concurrent disease, infection, or comorbidity that would preclude study; No other unstable medical conditions; No psychiatric disorders that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for at least 6 months after study

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Mark G. Kris,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000069341; MSKCC-01147; NCI-G02-2063; TLK-286.2004
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  May 13, 2002
ClinicalTrials.gov Identifier:  NCT00036920
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08