Clinical trial NCT00385996: Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer
Official title: A Pilot Study of Preoperative Tarceva (Erlotinib) Monotherapy in Patients With Early Stage (I/II) Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-small Cell Lung
Keywords: Carcinoma,non-small cell lung
preoperative
Tarceva
Response rate
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: OSI Pharmaceuticals
First posted: 2006-10-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Tarceva® (erlotinib) is a drug that blocks a receptor called the Epidermal Growth Factor Receptor (EGFR) on certain cells including tumor cells. Blocking this receptor has been shown to shrink tumors in some patients. Tarceva®(erlotinib) is approved for commercial use by the U.S. Food and Drug Administration for treatment of Non-Small Cell Lung Cancer (NSCLC) after failure of at least one chemotherapy treatment. However, it is not approved for the first treatment of Non-Small Cell Lung Cancer (NSCLC), which is the treatment used in this study.

Patients with early stage non-small cell lung cancer will receive daily Tarceva® (erlotinib) at 150 mg/day for 3 weeks followed by surgical resection at week 4. High resolution CT scans for tumor response assessment will be obtained at baseline and after 3 weeks of treatment with Tarceva® (erlotinib). Post-operative 2-year treatment with Tarceva® (erlotinib) will be offered to patients who had at least a 50% (half) decrease in size of their tumor after treatment with Tarceva® (erlotinib)and/or patients with tumors that were found to have the receptor, Epidermal Growth Factor Receptor (EGFR), on their tumor cells at the time of their surgery.

Post-operative chemotherapy will be administered at the discretion of the treating physician to patients with stages IB and II. Patients who receive post-operative chemotherapy will begin Tarceva (erlotinib)no sooner than 3 weeks from Day 1 of the last chemotherapy cycle and no longer than 6 months after surgery. Follow-up for recurrence and survival will continue for 2 years.

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.

Primary outcomes:
measure: Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction.
timeFrame: High resolution CT scans for response assessment will be obtained after 3 weeks of treatment with Tarceva®.
Secondary outcomes:
measure: Number of Participants With Grade 3, 4, or 5 Treatment Related Adverse Events as Assessed by CTCAE v3.0.
timeFrame: From Day 1 until 30 days after the last study drug dose,
measure: Time-to-progression (TTP)
timeFrame: Every 3 months for the first 6 months, then yearly for 2 years.
measure: Disease-free Survival (DFS)
timeFrame: From date of erlotinib start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 25 months.
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Nasser K Altorki, MD
role: PRINCIPAL_INVESTIGATOR
References: