Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer (6137p)

This study has been completed.
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
Novartis
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01011075
First received: October 14, 2009
Last updated: June 6, 2015
Last verified: June 2015

October 14, 2009
June 6, 2015
August 2009
July 2011   (final data collection date for primary outcome measure)
Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Response rates according to RECIST criteria (version 1.0) expressed as percentage of evaluable patients.
To estimate the clinical efficacy of the combination of weekly paclitaxel and intermittent imatinib in elderly patients with advanced non-small cell lung cancer. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01011075 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Overall survival as measured by the Kaplan-Meier method
  • Progression Free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of months post treatment without measurable progression according to RECIST criteria (version 1.0)
  • Toxicities [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Adverse events of grade 3 or higher, according to CTCAE version 3
To evaluate the safety profile of the combination of weekly paclitaxel and intermittent imatinib in elderly patients with advanced non-small cell lung cancer. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer
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

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.

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

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • 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
    Other Name: Gleevec
  • Drug: Paclitaxel
    Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Cycle length: 28 days Number of cycles: up to 6
    Other Name: Taxol
Experimental: Imatinib mesylate + Paclitaxel
Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Imatinib (Gleevec) 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
Interventions:
  • Drug: Imatinib mesylate
  • Drug: Paclitaxel
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. 2012 Oct 3;12:449. doi: 10.1186/1471-2407-12-449.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
July 2012
July 2011   (final data collection date for primary outcome measure)

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.
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01011075
INST CST1571BUS240, NCI-2011-02947, 6137p
Yes
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
  • Fred Hutchinson Cancer Research Center
  • Novartis
Principal Investigator: Julie Bauman, MD University of New Mexico Cancer Center
New Mexico Cancer Care Alliance
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP