Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

— 6137p  

Official title:

A Phase II Study of Intermittent Gleevec® (Imatinib Mesylate) and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011075
• Other study ID #: INST CST1571BUS240
• Secondary ID: NCI-2011-0294761
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2009
• Last updated: June 6, 2015
• Start date: August 2009
• Est. completion date: July 2012

Study information

• Verified date: June 2015
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the clinical efficacy of combining Gleevec (imatinib mesylate), a PDGFR antagonist, with front-line, single-agent paclitaxel in a cohort of elderly patients with advanced, non-small cell lung cancer.

Description:

Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Imatinib 600 mg/day, oral administration in 4-day pulses bracketing each paclitaxel infusion (days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Age = 70 years

• Histologic or cytologic diagnosis of non-small cell lung cancer

• At least one site of measurable disease, as defined by the modified RECIST criteria (See section 7.6)

• Stage IIIB with pleural effusion or Stage IV disease. Includes patients who received surgery alone for early stage disease, now in relapse with advanced disease. Staging is according to the American Joint Committee on Cancer classification scheme, 6th edition.48

• Adequate hepatic, renal and marrow function

• Liver function tests: total bilirubin < 1.25 x upper limit of normal (ULN), AST and ALT < 2.5 x ULN, Creatinine < 1.5 x ULN

• Baseline absolute neutrophil count > 1500/µL

• Baseline platelet count > 100,000/µL

• ECOG Performance Status 0, 1 or 2 at the time of informed consent. (See Appendix 1)

• Written, voluntary consent

• Patients with reproductive potential must use an acceptable contraceptive method. Such methods include: 1) Male hormonal contraception; 2) Partner without reproductive potential, including post-menopausal status or history of tubal ligation; 3) Partner with intrauterine device (IUD) or contraceptive vaginal ring; 4) Partner takes oral contraceptive pill, wears contraceptive patch, or has contraceptive implant; 5) Routine use of barrier method, such as condoms or diaphragm, during sexual intercourse.

Exclusion Criteria:

Uncontrolled brain metastasis. Patients with known brain metastasis must have completed treatment with surgery, radiation or both. In addition, they must be off corticosteroids.

• Symptomatic neuropathy (Grade 2 or higher)

• Prior chemotherapy for advanced non-small cell lung cancer. (Prior adjuvant, neoadjuvant, or chemoradiotherapy for NSCLC is permitted, provided at least 6 months elapsed prior to documented metastatic recurrence.)

• Patient is < 5 years free of another primary malignancy, except: a) if the other malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other primary malignancy is not considered clinically significant and is requiring no active intervention

• Prior radiation therapy to > 25% of bone marrow

• Grade III/IV congestive heart failure, as defined by NYHA criteria, or myocardial infarction within 6 months.

• Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.

• Patient has known chronic liver disease, e.g. diagnosis of chronic active hepatitis or cirrhosis.

• Major surgery two weeks prior to study treatment

• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent

• Any condition requiring continuous administration of systemic corticosteroids.

• The patient is on therapeutic anti-coagulation with warfarin.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Imatinib mesylate
Imatinib (Gleevec) 600 mg/day, oral administration in 4-day pulses(days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6
• Paclitaxel
Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Cycle length: 28 days Number of cycles: up to 6

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center @ Lovelace Medical Center	Albuquerque	New Mexico
United States	Univ. of Washington Fred Hutchinson Cancer Research Center (UW-FHCRC)	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance	Fred Hutchinson Cancer Research Center, Novartis

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bauman JE, Eaton KD, Wallace SG, Carr LL, Lee SJ, Jones DV, Arias-Pulido H, Cerilli LA, Martins RG. A Phase II study of pulse dose imatinib mesylate and weekly paclitaxel in patients aged 70 and over with advanced non-small cell lung cancer. BMC Cancer. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	Response rates according to RECIST criteria (version 1.0) expressed as percentage of evaluable patients.	6 months	Yes
Secondary	Overall Survival	Overall survival as measured by the Kaplan-Meier method	12 Months	No
Secondary	Progression Free Survival	Number of months post treatment without measurable progression according to RECIST criteria (version 1.0)	12 months	No
Secondary	Toxicities	Adverse events of grade 3 or higher, according to CTCAE version 3	12 months	Yes