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

This study has been terminated.
(Low accrual and PI leaving the institution.)
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: July 24, 2012
Last verified: July 2012
  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: Gleevec, 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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3
Study Start Date: August 2009
Study Completion Date: July 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gleevec, paclitaxel

    Each 28-day cycle includes three weekly doses of intravenous paclitaxel, administered on Day 3,10, and 17.

    Each 28-day cycle includes 12 daily doses of oral Gleevec (imatinib mesylate). Imatinib is administered in four-day pulses. Pulses bracket each paclitaxel infusion as follows: Days 1-4, Days 8-11, Days15-18. Each imatinib dose is 600 mg.

    Other Names:
    • Imatinib mesylate
    • gleevec
    • paclitaxel
  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 ntrauterine 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
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

No publications provided by New Mexico Cancer Care Alliance

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01011075     History of Changes
Other Study ID Numbers: INST CST1571BUS240
Study First Received: October 14, 2009
Last Updated: July 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
avanced non-small cell lung cancer

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 October 22, 2014