Status:
COMPLETED
Docetaxel, Cisplatin, and Erlotinib Hydrochloride in Treating Patients With Stage I-III Non-small Cell Lung Cancer Following Surgery
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Lung Non-Small Cell Carcinoma
Stage IA Lung Non-Small Cell Carcinoma AJCC v7
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies docetaxel, cisplatin, and erlotinib hydrochloride in treating patients with stage I-III non-small cell lung cancer following surgery. Drugs used in chemotherapy, such as doc...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the safety/toxicity of neoadjuvant chemotherapy with cisplatin and docetaxel followed by maintenance therapy with the epidermal growth factor receptor (EGFR) inhibi...
Eligibility Criteria
Inclusion
- 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
- No acute intercurrent illness or infection
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Leukocytes \>= 3,000/uL
- Absolute neutrophil count (ANC) \>= 1,500/uL
- Platelets \>= 100,000/uL
- Hemoglobin \>= 8g/dL
- Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- Bilirubin within normal institutional limits
- Alkaline phosphatase (alk phos) =\< 2.5 x upper limit of normal (ULN); if alk phos \> 2.5 x ULN but =\< 5 x ULN, patient is eligible if AST or ALT =\< ULN
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 1.5 x ULN; if AST or ALT \> 1.5 x ULN but =\< 5 x ULN, patient 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
- 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 National Cancer Institute (NCI) Common Toxicity Criteria (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
Key Trial Info
Start Date :
October 5 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00254384
Start Date
October 5 2005
End Date
May 21 2024
Last Update
July 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030