Pemetrexed or Docetaxel With or Without Erlotinib in Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 12, 2015 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Case Comprehensive Cancer Center
- Interventions being studied
- Drug: erlotinib hydrochloride; Drug: pemetrexed disodium; Drug: docetaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- Patient must be able to interrupt nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed (this
applies only to patients who have not received pemetrexed chemotherapy prior)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Wayne State UniversityDetroit, Michigan
- Columbia PresbyterianNew York, New York
- Lake/University Ireland Cancer CenterCleveland, Ohio
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio
- MetroHealth Medical CenterCleveland, Ohio
- UHHS Chagrin Highlands Medical CenterCleveland, Ohio
- Southwest General Health CenterCleveland, Ohio
- UHHS Westlake Medical CenterCleveland, Ohio
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio
- Riverside Methodist HospitalColumbus, Ohio
- Ohio State UniversityColumbus, Ohio
- UH-MonarchMayfield Heights, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 12, 2015. Always confirm current availability with the study team.