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
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Imatinib mesylate
Drug: Paclitaxel
Phase 2

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

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 34
Study Start Date: August 2009
Study Completion Date: July 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

Detailed 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

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011075

Locations
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
United States, Washington
Univ. of Washington Fred Hutchinson Cancer Research Center (UW-FHCRC)
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Fred Hutchinson Cancer Research Center
Novartis
Investigators
Principal Investigator: Julie Bauman, MD University of New Mexico Cancer Center
  More Information

Publications:
Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01011075     History of Changes
Other Study ID Numbers: INST CST1571BUS240, NCI-2011-02947, 6137p
Study First Received: October 14, 2009
Results First Received: February 1, 2013
Last Updated: June 6, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
Lung cancer,
Non-small cell lung cancer
NSCLC
Metastatic
Gleevec
elderly

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Imatinib
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on August 27, 2015