Tailored Second Line Treatment by Epidermal Growth Factor Receptor (EGFR) Mutation in Patients With Advanced Lung Adenocarcinoma

NCT00903292 | Unknown

• 1 other identifier: HR98004
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Currently the investigators have two different classes of second-line treatment options in recurrent non-small Cell Lung Cancer (NSCLC). In chemotherapy, docetaxel and pemetrexed produced similar treatment efficacy outcomes, while pemetrexed had a better tolerability. In recent analysis of pemetrexed clinical studies, a strong treatment-by-histology interaction in overall survival and progression free survival that indicated better efficacy for non-squamous patients treated with pemetrexed. These data supports that pemetrexed could be a preferable chemotherapy drug especially in adenocarcinoma NSCLC patients.

Conditions

Non-Small Cell Lung Cancer

Keywords

EGFR; NSCLC; EGFR mutation rate

Outcome Measures

Primary Outcomes (1)

• The primary analysis will be the overall best response rate, including a 95% confidence interval (Leemis and Trivedi 1996).

  02/2009 - 04/2010

Study Arms (2)

A, erlotinib

ACTIVE COMPARATOR

If EGFR mutation found then assigned to thyrosine kinase inhibitor (erlotinib)

Drug: erlotinib (Tarceva)

B, pemetrexed

ACTIVE COMPARATOR

If EGFR wild type found then assigned to chemotherapy (pemetrexed)

Drug: pemetrexed (Alimta)

Interventions

erlotinib (Tarceva) DRUG

chemotherapy with erlotinib

A, erlotinib

pemetrexed (Alimta) DRUG

Chemotherapy with pemetrexed

B, pemetrexed

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic diagnosis of adenocarcinoma of NSCLC.
• Locally advanced or metastatic disease (stage IIIB or IV), defined by the American Joint Committee on Cancer Staging Criteria for NSCLC (Fleming et al. 1997; Mountain 1997)
• Patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
• NOTE: First-line therapy with a tyrosine kinase inhibitor alone or regimens including pemetrexed, docetaxel, cetuximab, and trastuzumab is not allowed for enrollment in this study.
• Prior chemotherapy for earlier stage disease is allowed, but only a single regimen is allowed for prior palliative therapy of locally advanced or metastatic disease.
• Prior chemotherapy must be completed at least 2 weeks prior to study enrollment and the patient must have recovered from the acute toxic effects of the treatment.
• Disease status must be that of measurable disease as defined by RECIST criteria (Therasse et al. 2000).
• Performance status of 0 to 2 on the ECOG Scale (See Protocol Attachment 2.).
• Estimated life expectancy of at least 8 weeks.
• Adequate organ function including the following:
• Bone marrow: absolute neutrophil count (ANC) 1.5\* 109/L, platelets 100\*109/L, hemoglobin 9 g/dL.
• Hepatic: bilirubin 1.5ULN, AST and ALT 2.5 ULN (AST, ALT 5 ULN is acceptable if liver has tumor involvement).
• Renal: serum creatine 1.5 ULN; Calculated creatinine clearance 45 mL/min (using the standard Cockcroft-Gault formula; Cockcroft and Gault 1976).
• For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test and must not be lactating.
• For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after the treatment period.

You may not qualify if:

• Subject has untreated brain or meningeal metastases.
• CT scans are not required to rule out brain or meningeal metastases unless there is a clinical suspicion of central nervous system disease).
• Subjects with treated brain metastases that are radiographically or clinically stable for at least 2 weeks after therapy and have no evidence of cavitation or hemorrhage in the brain lesion are eligible providing that they are asymptomatic.
• Have previously completed or withdrawn from this study, or received pemetrexed, thymidylate synthetase or dihydrofolate reductase previously outside this study.
• Concurrent administration of any other tumor therapy.
• Active infection (at the discretion of the investigator).
• History of significant neurological or mental disorder, including seizures or dementia.
• Second primary malignancy that is clinically detectable within 5 years of consideration for study enrollment.
• Have received treatment within the last 30 days with a drug that has not received regulatory approval (e.g., warfarin or Coumadin) for any indication at the time of study entry.
• Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed.
• If a patient is taking an NSAID (Cox-2 inhibitors included) or salicylate with a long half-life (e.g., naproxen, piroxicam, diflunisal, nabumetone, rofecoxib, or celecoxib) it should not be taken 5 days before, the day of, and 2 days after the dose of pemetrexed.
• Inability or unwillingness to take erlotinib, folic acid, vitamin B12 supplementation, or dexamethasone.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Pemetrexed

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)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Wu-Chou Su, PhD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wu-Chou Su, PHD

CONTACT

886-6-2353535; sunnysu@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 18, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 18, 2009

Record last verified: 2009-05

Locations

TW (1)