Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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 first-line therapy with carboplatin and docetaxel.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Telik

Criteria

Inclusion Criteria:

• Histologically confirmed NSCLC

• Stage IIIb-Stage IV NSCLC

• ECOG performance status of 0-2

• Adequate liver and renal function

• Adequate bone marrow reserve

Exclusion Criteria:

• 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