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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sanofi
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00254384
First received: November 14, 2005
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

The goal of this clinical research study is 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. Another goal of this study is to look at changes that occur in epidermal growth factor receptor (EGFR) and how these changes are reflected in different cells in the body. 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, will also be studied.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Changes that occur in epidermal growth factor receptor (EGFR) and how these changes are reflected in different cells. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Safety of chemotherapy (cisplatin, docetaxel) given to patients whose lung cancer will be surgically removed, and erlotinib maintenance therapy given after surgery. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2005
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib + Cisplatin + Docetaxel
Erlotinib 150 mg by mouth daily for 1 year. Cisplatin 80 mg/m^2 IV over a 30 minutes - 1 hour infusion every 3 weeks (21 day cycle) for 3 cycles before surgery. Docetaxel 75 mg/m^2 IV over a 1 hour infusion every 3 weeks (21 day cycle) for 3 cycles before surgery.
Drug: Erlotinib
150 mg by mouth daily for 1 year.
Other Names:
  • Tarceva
  • OSI-774
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.
Other Names:
  • Platinol-AQ
  • Platinol
  • CDDP
Drug: Docetaxel
75 mg/m^2 IV over a 1 hour infusion every 3 weeks (21 day cycle) for 3 cycles before surgery.
Other Name: Taxotere

Detailed Description:

Erlotinib (Tarcevaâ, OSI-774) is a drug that helps to block the activity of an enzyme that is believed to play an important role in cell growth. It is hoped that blocking these enzymes will slow tumor growth. Both cisplatin and docetaxel (Taxotereâ) are commonly used chemotherapy drugs. These drugs are designed to target and destroy cancer cells.

If you are found to be eligible, you will begin receiving chemotherapy with cisplatin and docetaxel. Cisplatin and docetaxel will be given by vein once every 3 weeks. Both will be given on the same day every 3 weeks. Docetaxel is given first over 1 hour. Cisplatin is given second over 30 minutes to 1 hour. You will receive three 3-week cycles of chemotherapy while on this study. Treatment with erlotinib will begin after you have had surgery to remove the lung cancer. You will take erlotinib by mouth every day for the remainder of your treatment on this study.

While taking chemotherapy, you will have blood tests every 3 weeks to look at your blood counts. This is to ensure that your body has recovered from the chemotherapy enough to continue treatment. About 2 teaspoons of blood will be needed for each test. These samples will be used only for routine lab tests. You will be seen by a physician every 3 weeks. At these visits, you will have a physical exam and a chest x-ray. You may have a neurological exam if your doctor thinks it is necessary. This exam will look at whether you have any numbness, test your hearing and vision, and will include other standard evaluations. Your vital signs and weight will be monitored and you will be asked about certain side effects. If necessary, depending on your side effects, you may need to have more frequent visits to see your physician.

After 3 cycles of chemotherapy (9 weeks), you will have a CT scan of the chest and abdominal area, and possibly a CT scan of the area where the disease may be coming back. These are done to check the status of the disease.

Within 90 days after surgery, you will begin taking erlotinib. On Day 1 of erlotinib treatment, you will have a physical exam, a performance status evaluation (questions about your ability to perform everyday activities), a chest x-ray, and blood drawn (about 2 teaspoons) for routine tests. These tests will be repeated at Month 2, Month 3, then every 3 months after that.

On Day 1 of erlotinib treatment and every 3 months after that, you will also have a CT scan of the chest and abdominal area, and possibly a CT scan of the area where the disease may be coming back.

You may receive treatment in the study for up to 1 year (3 cycles of cisplatin/docetaxel and then daily erlotinib for up to 1 year) and will receive long-term follow-up (for 5 years total) with your physician to monitor your condition and disease status. Your doctor may decide to take you off this study if you experience significant side effects or your medical condition worsens. Follow-up visits will include a chest x-ray and CT scan every 3 months during Year 2 and then every 6 months until Year 5.

This is an investigational study. Erlotinib is approved by the FDA for treatment of non-small cell lung cancer. Its use in this study is experimental. Docetaxel and cisplatin are FDA approved and commercially available. A total of 50 patients will take part in this study. All will be enrolled at MD Anderson.

  Eligibility

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

Inclusion Criteria:

  1. 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.
  2. Patients must have surgically resectable disease and may not be treated with prior chemotherapy or radiation.
  3. Patients must be able to tolerate systemic chemotherapy prior to surgical resection.
  4. Age >=18 years
  5. No acute intercurrent illness or infection.
  6. ECOG performance status 0-1
  7. 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.
  8. 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.
  9. 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.
  10. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Patients who have had prior chemotherapy or radiotherapy for lung cancer.
  2. Patients may not be receiving any other investigational agents within 30 days of trial entry, including anti-EGFR drugs.
  3. Patient has signs or symptoms of acute infection requiring systemic therapy.
  4. Patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent.
  5. 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.
  6. Patients refusing to sign the informed consent.
  7. Patients with pre-existing peripheral neuropathy NCI CTC grade 2 or worse.
  8. 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.
  9. Patients with a history of severe hypersensitivity reaction to Taxotere® and or polysorbate 80 must be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Sanofi
Genentech, Inc.
Investigators
Principal Investigator: William N. William Jr., MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00254384     History of Changes
Other Study ID Numbers: 2004-0221, NCI-2012-01560
Study First Received: November 14, 2005
Last Updated: October 10, 2014
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Docetaxel
Erlotinib
Antimitotic Agents
Antineoplastic Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014