Clinical trial · Interventional
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
NCT01011075CI-TRIAL-000184506137pcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imatinib mesylate + Paclitaxel
- description
- 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
- interventionNames
- Drug: Imatinib mesylate
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- 6 months
- description
- Response rates according to RECIST criteria (version 1.0) expressed as percentage of evaluable patients.
Secondary outcomes (3)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTBauman 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. PMID 23033932