Pemetrexed or Docetaxel With or Without Erlotinib in Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00660816 | Completed Phase 2 Results DMC

• 3 other identifiers: CASE2507P30CA043703CASE-2507-CC350
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 13

Brief Summary

RATIONALE: Pemetrexed disodium and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving pemetrexed disodium or docetaxel together with erlotinib hydrochloride is more effective than giving pemetrexed disodium or docetaxel alone in treating non-small lung cancer. PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium or docetaxel together with or without erlotinib hydrochloride works in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  From the date of randomization to the date of disease progression or the date of death, whichever occurs first and censored at the date of last followed for those survivors without disease progression.

  18 months after enrollment of last patient

Secondary Outcomes (3)

• Overall Survival

  36 months after enrollment of last patient

• Response Rate

  36 months after enrollment of last evaluable patient

• Disease Stabilization Rate (e.g., Complete Response, Partial Response, and Stable Disease)

  36 months after enrollment of last patient

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients receive pemetrexed disodium IV over 10 minutes OR docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive standard chemotherapy with or without erlotinib hydrochloride in the absence of disease progression or unacceptable toxicity.

Drug: pemetrexed disodium; Drug: docetaxel

Arm II

EXPERIMENTAL

Patients receive pemetrexed disodium IV over 10 minutes OR docetaxel IV over 60 minutes on day 1 and erlotinib hydrochloride PO once daily on days 2-19. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive standard chemotherapy with or without erlotinib hydrochloride in the absence of disease progression or unacceptable toxicity.

Drug: erlotinib hydrochloride; Drug: pemetrexed disodium; Drug: docetaxel

Interventions

erlotinib hydrochloride DRUG

Given orally once daily on days 2-19.

Also known as: erlotinib

Arm II

pemetrexed disodium DRUG

Given IV over 10 minutes on day 1

Also known as: MTA

Arm I; Arm II

docetaxel DRUG

IV over 60 minutes on day 1.

Also known as: TXT

Arm I; Arm II

Eligibility Criteria

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

You may qualify if:

• Pathologic diagnosis of stage IIIB (with pleural effusion) or IV non-small cell lung cancer
• Progression following at least twelve weeks of treatment with single-agent erlotinib (or in combination with other experimental agents) during which time the patients experienced a clinical benefit as assessed by his/her treating physician and corroborated by radiographic assessment (at least one CT scan following at least 4 weeks of erlotinib monotherapy demonstrating stable disease or response on erlotinib therapy).
• At least one measurable lesion as defined by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Life expectancy of at least 12 weeks
• Absolute neutrophil count (ANC) \>= 1.5x10(9)/L
• Platelet count \>= 100x 10(9)
• Hemoglobin \>= 8.0 g/dl
• Serum creatinine =\< 1.5 upper limit of normal OR calculated creatinine clearance \>= 45 mL/min
• Total bilirubin =\< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
• Available baseline diagnostic tumor specimen for correlative studies, any diagnostic material will be acceptable- paraffin block, cell block, fine needle aspirate etc.
• Patients must provide verbal and written informed consent to participate in the study
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
• Patient must be able to take folic acid, vitamin B12 as well as dexamethasone therapy as per protocol guidelines

You may not qualify if:

• Active central nervous system disease (CNS) metastases, as indicated by clinical symptoms, cerebral edema or progressive growth (subjects with a clinical history of CNS metastases or cord compression are allowable if they have been definitively treated and are clinically stable for at least 4 weeks before first dose of study treatment for prior whole brain radiation and 2 weeks for prior gamma knife therapy)
• More than 1 prior cytotoxic chemotherapy regimen for relapsed or metastatic disease (not including erlotinib)
• Any prior epidermal growth factor receptor (EGFR) inhibitor therapy except for erlotinib
• Major surgery, chemotherapy, or investigational agents within 3 weeks of treatment day 1 (except for erlotinib). Radiation therapy within 2 weeks of treatment day 1 (except for erlotinib).
• Prior treatment with both pemetrexed and docetaxel chemotherapy
• Pregnancy or breastfeeding or not receiving adequate contraception (including the patients spouse)
• Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
• Patients who must receive pemetrexed and have the presence of third space fluid which cannot be controlled by drainage
• Patients who must receive docetaxel and who have peripheral neuropathy \> grade 2
• Patients who must receive docetaxel and who have had a hypersensitivity reaction to medications formulated with polysorbate 80

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (13)

Wayne State University

Detroit, Michigan, 48202, United States

Location

Columbia Presbyterian

New York, New York, 10032, United States

Location

Lake/University Ireland Cancer Center

Cleveland, Ohio, 44060, United States

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, 44122, United States

Location

Southwest General Health Center

Cleveland, Ohio, 44130, United States

Location

UHHS Westlake Medical Center

Cleveland, Ohio, 44145, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43124, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

UH-Monarch

Mayfield Heights, Ohio, 44124, United States

Location

UH-Firelands

Sandusky, Ohio, 44870, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Pemetrexed; Docetaxel

Condition Hierarchy (Ancestors)

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

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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Afshin Dowlati
• Organization: CCCC

afshin.dowlati@uhhospitals.org

216-844-1228

Study Officials

• Afshin Dowlati, MD

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 17, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2015
• Last Updated: October 12, 2015
• Results First Posted: August 5, 2014

Record last verified: 2015-10

Locations

US (13)