Phase 2
N=82
Ixabepilone and Carboplatin +/- Bevacizumab in Advanced Non-Small-Cell Lung Cancer
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00741988 ↗Enrolled (actual)
82
Serious AEs
39.0%
Results posted
Feb 2013
Primary outcome: Primary: Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment — 29; 50 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ixabepilone (Drug); Carboplatin (Drug); Bevacizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SCRI Development Innovations, LLC
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment |
29; 50 | — |
| SECONDARY Progression Free Survival, the Length of Time, That Patients Were Alive From Their First Date of Treatment Until Worsening of Their Disease |
5.3; 6.7 | — |
| SECONDARY Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death |
9.3; 13.2 | — |
| SECONDARY Number of Participants Experiencing Treatment Related Toxicity |
4; 6; 6; 9; 13; 19 | — |
Summary
This is a multicenter, non-randomized, Phase II study of patients with previously untreated NSCLC not amenable to radiotherapy or surgical treatment. The planned enrollment for this trial is 78 patients (including a 10% rate for inevaluable patients). There will be a total of 39 patients in each cohort (Cohorts A and B).
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed non-small-cell bronchogenic carcinoma (squamous carcinoma, adenocarcinoma, or large cell carcinoma). Cytologic specimens obtained by brushings, washings, or needle aspiration of the defined lesion are acceptable. Mixed tumors with small-cell anaplastic elements are not eligible.
- Patients who have newly diagnosed unresectable stage III or IV disease are eligible. Patients with stage III disease should be ineligible for combined modality therapy
- Patients must not have received any prior antineoplastic chemotherapy for metastatic lung cancer prior to study entry.
- Patients who have had previous radiotherapy as definitive therapy for locally advanced non-small-cell are eligible as long as the recurrence is outside the original radiation port. Radiation therapy must have been completed greater than 4 weeks prior to registration.
- Male or female patients >=18 years of age.
- Life expectancy of at least 3 months.
- ECOG performance status of =1500/mm3 (7 days prior to treatment);
- Hemoglobin >=8 g/dL;
- Platelets >=100, 000 mm3 (7 days prior to treatment)
- Bilirubin =40 mL/min
- PT/INR and PTT grade 2 per New York Heart Association (NYHA) criteria (see Appendix B), myocardial infarction within the previous 6 months, or symptomatic cardiac arrhythmias.
- Metastatic brain or meningeal tumors.
- Uncontrolled intercurrent illness.
- Chemotherapy, investigational drug therapy, or major surgery ≤ 4 weeks prior to starting study drug, or patients who have not recovered from side effects of previous therapy.
- Patient is =1.0 or
- Urine dipstick for protein >=2+ (patients discovered to have >=2+ proteinuria on dipstick at baseline should undergo a 24-hour urine collection, and must demonstrate <1 g of protein in 24 hours to be eligible).
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning bevacizumab.
Data sourced from ClinicalTrials.gov (NCT00741988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.