Status:
TERMINATED
Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer
Lead Sponsor:
Telik
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving fir...
Detailed Description
TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving fir...
Eligibility Criteria
Inclusion
- Histologically confirmed NSCLC
- Stage IIIb-Stage IV NSCLC
- ECOG performance status of 0-2
- Adequate liver and renal function
- Adequate bone marrow reserve
Exclusion
- Treatment with neoadjuvant or adjuvant chemotherapy within 1 year
- Histologically confirmed mixed tumors containing small cell elements
- Treatment with radiotherapy (except limited in nature) within 3 weeks of randomization
- History of bone marrow transplantation or stem cell support
- Known history of CNS metastasis unless the patient has had treatment with surgery or radiotherapy, is neurologically stable and does not require oral or IV steroids or anticonvulsants
- History of HIV
- Grade 3 or 4 peripheral neuropathy
- Weightloss greater than 5% within 6 months
- Uncontrolled pleural effusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00701870
Start Date
October 1 2008
End Date
November 1 2008
Last Update
November 27 2013
Active Locations (24)
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1
Central Hematology Oncology Medical Group
Alhambra, California, United States, 91801
2
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
3
Providence St. Joseph Medical Center
Burbank, California, United States, 91505
4
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835