Phase 2
Completed N=120
A Study of Pemetrexed Plus Carboplatin, or Pemetrexed Plus Cisplatin With Radiation Therapy Followed by Pemetrexed in Patients With Inoperable Non-Small-Cell Lung Cancer
Source: ClinicalTrials.gov NCT00482014 ↗Enrolled (actual)
120
Serious AEs
42.5%
Results posted
Nov 2012
Primary outcomePrimary: Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin — NA milligram/milliliter*minute (mg/mL*min)
Summary
The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin |
NA | — |
| PRIMARY Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin |
NA | — |
| PRIMARY Phase 2 - Survival Probability at 2 Years |
45.4; 58.4 | — |
| SECONDARY Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs) |
1; 0; 0; 1 | — |
| SECONDARY Phase 1 - Percentage of Participants With Complete Response or Partial Response (Response Rate) |
0; 0; 11.1; 45.5 | — |
| SECONDARY Phase 2 - Pharmacology Toxicity: Number of Participants With Adverse Events |
21; 19; 44; 51 | — |
| SECONDARY Phase 2 - Time to Progression |
8.8; 13.1 | — |
| SECONDARY Phase 2 - Median Survival |
18.7; 27.0 | — |
| SECONDARY Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate) |
6.5; 3.8; 45.7; 42.3 | — |
Eligibility Criteria
Inclusion Criteria
- Inoperable non small cell lung cancer
- No weight loss greater than 10% in 3 months prior to enrolling in trial
- Adequate kidney function
- Adequate liver function
- Adequate lung function
Exclusion Criteria
- Previous surgery to remove lung tumor
- Previous chemotherapy or radiation therapy or lung cancer
- Inability to take vitamin supplementation
- Heart attack within past 6 months
- Active infection
Data sourced from ClinicalTrials.gov (NCT00482014). 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. Informational only — not medical advice.