Neoadjuvant, Tarceva, Surgery for Non-Small Cell Lung Cancer (NSCLC)

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Neoadjuvant, Tarceva, Surgery for Non-Small Cell Lung Cancer (NSCLC)
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, January 2009
Sponsors and Collaborators: M.D. Anderson Cancer Center
Sanofi-Aventis
Genentech

Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00254384

Purpose
Primary objectives are:

To evaluate the safety/toxicity of neoadjuvant chemotherapy with cisplatin and docetaxel followed by maintenance therapy with the EGFR inhibitor erlotinib in patients with stage I-III non-small cell lung cancer (NSCLC) undergoing definitive treatment with surgery and/or radiation.
To estimate the agreement in baseline to post-treatment changes of EGFR expression (i.e., EGFR modulation) between buccal smears and bronchial tissue.
Secondary objectives are:

To evaluate the disease free survival of this therapeutic combination.
To assess overall quality of life.
To evaluate predictive biomarkers in early-stage NSCLC.


Condition Intervention
Lung Cancer
Drug: Erlotinib
Drug: Cisplatin
Drug: Docetaxel




MedlinePlus related topics: Cancer Lung Cancer Surgery
Drug Information available for: Docetaxel Cisplatin Erlotinib Erlotinib hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Neoadjuvant Chemotherapy With Docetaxel, Cisplatin Followed by Maintenance Therapy With the EGFR Inhibitor Erlotinib (Tarceva) in Patients With Stage I, II and III Non-Small Cell Lung Cancer Following Definitive Surgical Resection


Further study details as provided by M.D. Anderson Cancer Center:


Primary Outcome Measures:
To look at changes that occur in epidermal growth factor receptor (EGFR) and how these changes are reflected in different cells in the body. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

To learn if chemotherapy (cisplatin, docetaxel) is safe to give to patients whose lung cancer will be surgically removed, and to learn if maintenance therapy with the biologic agent erlotinib, given after surgery, is safe. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]



Secondary Outcome Measures:
To study the effect of this treatment on the participant's quality of life and survival, as well as its effect on different cells in the body. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]


Estimated Enrollment: 40
Study Start Date: October 2005
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Erlotinib + Cisplatin + Docetaxel Drug: Erlotinib
150 mg by mouth daily for 1 year.
Drug: Cisplatin
80 mg/m^2 IV over a 30 minutes - 1 hour infusion every 3 weeks (21 day cycle) for 3 cycles before surgery.
Drug: Docetaxel
75 mg/m^2 IV over a 1 hour infusion every 3 weeks (21 day cycle) for 3 cycles before surgery.


Show Detailed Description


Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
Inclusion Criteria:

Patients must have histologically or cytologically confirmed diagnosis of stage I, II or III non-small cell lung cancer. Tissue blocks or slides will be requested.
Patients must have surgically resectable disease and may not be treated with prior chemotherapy or radiation.
Patients must be able to tolerate systemic chemotherapy prior to surgical resection.
Age >=18 years
No acute intercurrent illness or infection.
ECOG performance status 0-1
Normal organ and marrow function defined as: a) leukocytes >=3,000/uL, ANC>=1,500/uL, platelets>=100,000/uL, hemoglobin>=8g/dL, creatinine w/in normal institutional limits OR b) creatinine clearance>=60 mL/min/1.73 m**2 for patients with creatinine levels above institutional normal, bilirubin w/in normal institutional limits, alk phos<=2.5xULN AND AST or ALT<=1.5xULN. If alk phos>2.5xULN but <=5xULN, pt is eligible if AST or ALT<=ULN. If AST or ALT>1.5xULN but <=5xULN, pt is eligible if alk phos is <=ULN.
Prior to study enrollment, all women of child-bearing potential must have a negative pregnancy test. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 2 months after the completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Patients with a history of non-melanoma skin cancer, or other malignancies treated 5 years or more prior to the current tumor, from which the patient has remained continually disease-free, are eligible.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:

Patients who have had prior chemotherapy or radiotherapy for lung cancer.
Patients may not be receiving any other investigational agents within 30 days of trial entry, including anti-EGFR drugs.
Patient has signs or symptoms of acute infection requiring systemic therapy.
Patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Functional Classification class II or worse), unstable angina pectoris, serious or clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients refusing to sign the informed consent.
Patients with pre-existing peripheral neuropathy NCI CTC grade 2 or worse.
Patients must not be pregnant or breast-feeding and all (male and female) must use a contraceptive method deemed acceptable by the investigator while receiving active treatment in the study and for up to two months following completion of therapy.
Patients with a history of severe hypersensitivity reaction to Taxotere® and or polysorbate 80 must be excluded.
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254384


Contacts
Contact: Warner Tse, R.N. 713-563-4666 wtse@mdanderson.org


Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Warner Tse, RN 713-563-4666 wtse@mdanderson.org
Principal Investigator: Edward S. Kim, MD

Sponsors and Collaborators
M.D. Anderson Cancer Center
Sanofi-Aventis
Genentech
Investigators
Principal Investigator: Edward S. Kim, MD U.T.M.D. Anderson Cancer Center

More Information


UT MD Anderson Cancer Center

Responsible Party: University of Texas M.D. Anderson Cancer Center ( Edward S. Kim, M.D./Assistant Professor )
Study ID Numbers: 2004-0221
Study First Received: November 14, 2005
Last Updated: January 20, 2009
ClinicalTrials.gov Identifier: NCT00254384 [history]
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Non-Small Cell Lung Cancer
Lung Cancer
Cisplatin
Platinol
Platinol-AQ
CDDP
Docetaxel
Taxotere
Erlotinib
Tarceva
OSI-774
NSCLC



Study placed in the following topic categories:
Erlotinib
Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions



ClinicalTrials.gov processed this record on February 10, 2009


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