Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
This phase II trial is studying how well docetaxel given together with cisplatin and pegfilgrastim followed by erlotinib hydrochloride works in treating patients with stage IIIB or stage IV non-small cell lung cancer. 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 or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving dose-dense combination chemotherapy together with pegfilgrastim and erlotinib hydrochloride may kill more tumor cells
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 6 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jun 29, 2018 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Wake Forest University Health Sciences
- Interventions being studied
- Drug: cisplatin; Biological: pegfilgrastim; Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis; Genetic: polymorphism analysis; Other: pharmacogenomic studies; Genetic: genetic linkage analysis; 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.
- Histologic Documentation: Either histologic or cytologic documentation of non-small cell carcinoma (NSCLC) is necessary, and the following diagnostic categories are acceptable: squamous carcinoma, basaloid carcinoma, adenocarcinoma, bronchioloalveolar carcinoma, adenosquamous carcinoma, large cell carcinoma (not neuroendocrine), sarcomatoid carcinoma, and non-small cell carcinoma not otherwise specified (NOS); histologic or cytologic documentation of recurrence is required in patients who were previously completely resected
- Advanced Disease: Stage IIIB because of malignant pleural or pericardial effusion or stage IV disease
- Patients must be ineligible for Avastin or decline treatment with Avastin
- Prior Treatment: No prior chemotherapy or treatment with an EGFR inhibitor is allowed; brain metastasis must be under control (patient neurologically stable)
- All Patients must have Measurable or Non-Measurable Disease: measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension; the longest diameter of measurable lesions must be \>= 20 mm with conventional techniques or \>= 10 mm with spiral computed tomography (CT) scan; non-measurable disease includes the following:
- Bone lesions
- Brain metastasis or leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions situated in a previously irradiated area
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Granulocytes \>= 1,500/ul
- Platelets \>= 100,000/ul
- Creatinine =\< upper limit of normal (ULN)
- Bilirubin =\< 1.5 mg/dl
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 1.5 x ULN
- Alkaline (Alk.) phosphatase (phos.) =\< 2.5 x ULN
- Patients must provide verbal and written informed consent to participate in the study
- Patients who are pregnant or nursing because of significant risk to the fetus/infant
- Patients with neuropathy \>= grade 2
- Patients with a psychiatric illness which would prevent the patient from giving informed consent
- Patients who are unable to take oral medications
- Women with child-bearing potential or men who are sexual partners of women with child-bearing potential who are not willing to practice adequate contraceptive measures
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Wake Forest University Health SciencesWinston-Salem, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 29, 2018. Always confirm current availability with the study team.