Phase 2
N=46
Pemetrexed or Docetaxel With or Without Erlotinib in Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00660816 ↗Enrolled (actual)
46
Serious AEs
45.7%
Results posted
Aug 2014
Primary outcome: Primary: Progression-free Survival — 5.5; 4.4 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- erlotinib hydrochloride (Drug); pemetrexed disodium (Drug); docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
5.5; 4.4 | — |
| SECONDARY Overall Survival |
16.4; 14.2 | — |
| SECONDARY Response Rate |
2; 3 | — |
| SECONDARY Disease Stabilization Rate (e.g., Complete Response, Partial Response, and Stable Disease) |
15; 16 | — |
Summary
RATIONALE: Pemetrexed disodium and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving pemetrexed disodium or docetaxel together with erlotinib hydrochloride is more effective than giving pemetrexed disodium or docetaxel alone in treating non-small lung cancer.
PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium or docetaxel together with or without erlotinib hydrochloride works in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Eligibility Criteria
INCLUSION CRITERIA
- Pathologic diagnosis of stage IIIB (with pleural effusion) or IV non-small cell lung cancer
- Progression following at least twelve weeks of treatment with single-agent erlotinib (or in combination with other experimental agents) during which time the patients experienced a clinical benefit as assessed by his/her treating physician and corroborated by radiographic assessment (at least one CT scan following at least 4 weeks of erlotinib monotherapy demonstrating stable disease or response on erlotinib therapy).
- At least one measurable lesion as defined by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Life expectancy of at least 12 weeks
- Absolute neutrophil count (ANC) >= 1.5x10(9)/L
- Platelet count >= 100x 10(9)
- Hemoglobin >= 8.0 g/dl
- Serum creatinine = = 45 mL/min
- Total bilirubin = grade 2
- Patients who must receive docetaxel and who have had a hypersensitivity reaction to medications formulated with polysorbate 80
Data sourced from ClinicalTrials.gov (NCT00660816). 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.