Phase 2
N=22
Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer
Carcinoma, Non-small Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT00385996 ↗Enrolled (actual)
22
Serious AEs
18.2%
Results posted
Nov 2012
Primary outcome: Primary: Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction. — 1 Participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tarceva (Erlotinib) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction. |
1 | <0.01 sig |
| SECONDARY Number of Participants With Grade 3, 4, or 5 Treatment Related Adverse Events as Assessed by CTCAE v3.0. |
2 | — |
| SECONDARY Time-to-progression (TTP) |
13.9 | — |
| SECONDARY Disease-free Survival (DFS) |
22.7 | — |
Summary
The main purpose of this study is to see if Tarceva® (erlotinib) is effective in shrinking tumors. A high resolution CT scan (CT scanner that can view 3 dimensional images of the tumor) will be used to measure the tumor before and after treatment with Tarceva®(erlotinib) . This type of CT scan will measure the tumor by volume and by standard measurement (length and width). Both methods will be compared to find out whether standard measurement or measurement by tumor volume is more accurate.
Eligibility Criteria
Inclusion Criteria
- Biopsy proven stage I/II non-small cell lung cancer who are candidates for surgical resection
- Ambulatory and capable of all self-care but may be unable to carry out any work activities.
- Preoperative and postoperative high resolution CT scans done at NYPH-Weill Cornell medical center for purposes of volumetric measurements.
- Acceptable cardiac, breathing, kidney, liver, and bone marrow functions.
- 18 years and older.
- Women of child-bearing potential must be taking adequate contraceptive precautions prior to study entry and for the duration of study participation. A negative serum or urine pregnancy test is required within 7-10 days of Tarceva® administration. Men and premenopausal women of child bearing potential will follow an approved, medically accepted birth control regimen or agree to abstain from heterosexual intercourse while taking study drug and for 30 days following the last dose of study drug.
Exclusion Criteria
- Cannot be on any other anti-cancer treatment during this study.
- Prior treatment with any EGFR inhibitor.
- Patients who had prior treatment with chemotherapy or radiation for this disease.
- Other active cancers.
- Tumors with a mixed histology of small cell and non-small cell carcinoma as well as patients with pulmonary carcinoid tumors.
- Gastro-intestinal abnormalities, including active peptic ulcer or inflammatory bowel disease.
- Hypersensitivity to compounds similar in chemical composition to Tarceva®.
- Active infection or serious underlying medical conditions which would impair protocol treatment.
Data sourced from ClinicalTrials.gov (NCT00385996). 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.