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

Telik

Status and phase

Terminated

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: ezatiostat hydrochloride (Telintra®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00701870

TLK199.2102

Details and patient eligibility

About

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.

Full description

After randomization, patients in Treatment Arm 1, chemotherapy with carboplatin and docetaxel will be administered on Day 1 of each cycle, followed by Telintra at a starting dose of 3000 mg total daily dose (1500 mg orally, twice daily) on Day 2 until the absolute neutrophil count improves as confirmed by two consecutive measurement at least 24 hours apart. In Treatment Arm 2 (control arm), chemotherapy alone consisting of carboplatin and docetaxel will be administered on Day 1 of each cycle.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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