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

Sponsor

Telik (Industry)

Overall Status

Terminated

CT.gov ID

NCT00701870

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 first-line therapy with carboplatin and docetaxel.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: ezatiostat hydrochloride (Telintra®)	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Chemotherapy Induced Neutropenia in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Receiving First-Line Chemotherapy

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ezatiostat hydrochloride (Telintra®) Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery	Drug: ezatiostat hydrochloride (Telintra®) 4500 mg orally per day in two divided doses Other Names: Telintra tablets ezatiostat tablets
No Intervention: No Intervention Chemotherapy with docetaxel and carboplatin alone

Arm

Intervention/Treatment

Experimental: ezatiostat hydrochloride (Telintra®)

Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery

Drug: ezatiostat hydrochloride (Telintra®)

4500 mg orally per day in two divided doses

Other Names:

Telintra tablets

ezatiostat tablets

No Intervention: No Intervention

Chemotherapy with docetaxel and carboplatin alone

Outcome Measures

Primary Outcome Measures

Duration of chemotherapy induced neutropenia [6 weeks]

Secondary Outcome Measures

Duration of chemotherapy induced severe neutropenia [6 weeks]
Time to ANC recovery from ANC nadir [6 weeks]
Incidence of febrile neutropenia [6 weeks]
Incidence of G-CSF administration [6 weeks]
FACT-N quality of life assessment [6 weeks]
safety assessments [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Wilshire Oncology Medical Group	La Verne	California	United States	91750
6	UCLA Medical Center	Los Angeles	California	United States	90095
7	Clinical Trials and Research Associates, Inc.	Montebello	California	United States	90640
8	North Valley Hematology/Oncology Medical Group	Northridge	California	United States	91325
9	Ventura County Hematology-Oncology Specialists	Oxnard	California	United States	93030
10	Samsum Clinic	Santa Barbara	California	United States	93105
11	Santa Barbara Hematology Oncology Medical Group, Inc.	Santa Barbara	California	United States	93105
12	Central Coast Medical Oncology Corporation	Santa Maria	California	United States	93454
13	Broward Oncology Associates	Ft. Lauderdale	Florida	United States	33308
14	Nature Coast Clinical Research	Inverness	Florida	United States	34452
15	Lakeland Regional Cancer Center	Lakeland	Florida	United States	33805
16	Florida Hospital Cancer Institute	Ormand Beach	Florida	United States	32174
17	Suburban Hematology-Oncology Associates, PC	Lawrenceville	Georgia	United States	30045
18	Medical & Surgical Specialists	Galesburg	Illinois	United States	61401
19	Joliet Oncology/Hematology Associates, Ltd.	Joliet	Illinois	United States	60435
20	Comprehensive Cancer Centers of Nevada	Henderson	Nevada	United States	89052
21	Montefiore Medical Center	Bronx	New York	United States	10467
22	Case Medical Center-University Hospitals	Cleveland	Ohio	United States	44106
23	The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
24	Coastal Cancer Center	Myrtle Beach	South Carolina	United States	29572-4128