Clinical trial NCT01011075: Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Lung cancer,
Non-small cell lung cancer
NSCLC
Metastatic
Gleevec
elderly
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
Collaborators: name: Fred Hutchinson Cancer Center
name: Novartis
First posted: 2009-11-11
Enrollment: 34
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Response Rate
timeFrame: 6 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 12 Months
measure: Progression Free Survival
timeFrame: 12 months
measure: Toxicities
timeFrame: 12 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center @ Lovelace Medical Center
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Seattle
country: United States
facility: Univ. of Washington Fred Hutchinson Cancer Research Center (UW-FHCRC)
state: Washington
Study officials:
affiliation: University of New Mexico Cancer Center
name: Julie Bauman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.