Phase 2
N=62
Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients
Non Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00350792 ↗Enrolled (actual)
62
Serious AEs
41.9%
Results posted
Dec 2009
Primary outcome: Primary: Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response) — 28.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pemetrexed (Drug); carboplatin (Drug)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response) |
28.6 | — |
| SECONDARY Time to Treatment Failure |
16.0 | — |
| SECONDARY Overall Survival |
10.4 | — |
| SECONDARY Estimated Probability of One Year Progression-free Survival |
13.1 | — |
Summary
A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer
Eligibility Criteria
Inclusion Criteria
- Pathologically confirmed Non Small Cell Lung Cancer Stage IIIb (not amenable to radiotherapy treatment) or Stage IV
- No previous chemotherapy for lung cancer
- Men and women > or = 70 years
- At least one uni-dimensionally measurable lesion (Response Evaluation Criteria In Solid Tumors [RECIST]criteria)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
Exclusion Criteria
- Treatment within the last 30 days with a drug that has not received regulatory approval
- Serious systemic disorders
- Inability to discontinue administration of aspirin or anti-inflammatory non steroid
- Concurrent administration of any other antitumor therapy
- Brain metastasis
Data sourced from ClinicalTrials.gov (NCT00350792). 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.