Docetaxel, Cisplatin, and Erlotinib Hydrochloride in Treating Patients With Stage I-III Non-small Cell Lung Cancer Following Surgery

NCT00254384 | Completed Phase 1 FDA Drug

• 3 other identifiers: 2004-0221NCI-2012-01560NCI-2010-00817
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Rate of grade 3 or greater toxicities (hematologic or non-hematologic)

  Up to 5 years post-treatment

• Changes of EGFR expression (i.e., EGFR modulation) between buccal smears and bronchial tissue

  Agreement will be estimated using the kappa coefficient. An important aspect of this trial is to identify changes in expression of potential biomarkers between buccal smears and bronchial tissues after induction (neoadjuvant) platinum-based therapy in early-stage , resectable non-small cell lung cancers. As part of the primary outcome measures, we plan to measure the EGFR expression changes (i.e. EGFR modulation) between buccal smears and bronchial tissues after induction therapy.

  From baseline up to 5 years post-treatment

Secondary Outcomes (3)

• Incidence of EGFR mutations

  Up to 5 years post-treatment

• Evaluation of immune-based biomarkers

  Up to 5 years post-treatment

• Time to progression

  Up to 5 years post-treatment

Study Arms (1)

Treatment (docetaxel, cisplatin, erlotinib hydrochloride)

EXPERIMENTAL

Patients receive docetaxel 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 PO daily for up to 1 year.

Drug: Cisplatin; Drug: Docetaxel; Drug: Erlotinib; Drug: Erlotinib Hydrochloride; Other: Laboratory Biomarker Analysis

Interventions

Cisplatin DRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone''s Chloride, Peyrone''s Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Treatment (docetaxel, cisplatin, erlotinib hydrochloride)

Docetaxel DRUG

Given IV

Also known as: Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

Treatment (docetaxel, cisplatin, erlotinib hydrochloride)

Erlotinib DRUG

Given PO

Treatment (docetaxel, cisplatin, erlotinib hydrochloride)

Erlotinib Hydrochloride DRUG

Given PO

Also known as: Cp-358,774, OSI-774, Tarceva

Treatment (docetaxel, cisplatin, erlotinib hydrochloride)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (docetaxel, cisplatin, erlotinib hydrochloride)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 29217088 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Docetaxel; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tina Cascone, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2005
• First Posted: November 16, 2005
• Study Start: October 5, 2005
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

US (1)