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Phase II Study Of TLK286 For The Treatment Of Advanced Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

Phase II Study Of TLK286 For The Treatment Of Advanced Non-Small Cell Lung Cancer

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.

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

Inclusion 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

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Mark G. Kris, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2002

Completion Date:

December 2009

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • bronchoalveolar cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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