Clinical trial NCT00254384: Docetaxel, Cisplatin, and Erlotinib Hydrochloride in Treating Patients With Stage I-III Non-small Cell Lung Cancer Following Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recurrent Lung Non-Small Cell Carcinoma
Stage IA Lung Non-Small Cell Carcinoma AJCC v7
Stage IB Lung Non-Small Cell Carcinoma AJCC v7
Stage IIA Lung Non-Small Cell Carcinoma AJCC v7
Stage IIB Lung Non-Small Cell Carcinoma AJCC v7
Stage IIIA Lung Non-Small Cell Cancer AJCC v7
Stage IIIB Lung Non-Small Cell Cancer AJCC v7
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-11-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel, cisplatin, and erlotinib hydrochloride together may kill more tumor cells.

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) inhibitor erlotinib (erlotinib hydrochloride) in patients with stage I-III non-small cell lung cancer (NSCLC) undergoing definitive treatment with surgery and/or radiation.

II. 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:

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

OUTLINE:

Patients receive docetaxel intravenously (IV) over 1 hour followed by cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning within 90 days following definitive surgical resection, patients receive erlotinib hydrochloride orally (PO) daily for up to 1 year.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.

Eligibility 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
* 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 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 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

Primary outcomes:
measure: Rate of grade 3 or greater toxicities (hematologic or non-hematologic)
timeFrame: Up to 5 years post-treatment
measure: Changes of EGFR expression (i.e., EGFR modulation) between buccal smears and bronchial tissue
timeFrame: From baseline up to 5 years post-treatment
Secondary outcomes:
measure: Incidence of EGFR mutations
timeFrame: Up to 5 years post-treatment
measure: Evaluation of immune-based biomarkers
timeFrame: Up to 5 years post-treatment
measure: Time to progression
timeFrame: Up to 5 years post-treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Tina Cascone, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cascone T, Gold KA, Swisher SG, Liu DD, Fossella FV, Sepesi B, Pataer A, Weissferdt A, Kalhor N, Vaporciyan AA, Hofstetter WL, Wistuba II, Heymach JV, Kim ES, William WN Jr. Induction Cisplatin Docetaxel Followed by Surgery and Erlotinib in Non-Small Cell Lung Cancer. Ann Thorac Surg. 2018 Feb;105(2):418-424. doi: 10.1016/j.athoracsur.2017.08.052. Epub 2017 Dec 6.