Phase 2
N=45
Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Adenocarcinoma of the Lung · Adenosquamous Cell Lung Cancer · Bronchoalveolar Cell Lung Cancer · Large Cell Lung Cancer · Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01557959 ↗Enrolled (actual)
45
Serious AEs
88.6%
Results posted
Jun 2013
Primary outcome: Primary: Time to Progression — 4.63 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cisplatin (Drug); pegfilgrastim (Biological); erlotinib hydrochloride (Drug); laboratory biomarker analysis (Other); polymorphism analysis (Genetic); pharmacogenomic studies (Other); genetic linkage analysis (Genetic); docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression |
4.63 | — |
| SECONDARY Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood |
3; 4; 9; 9; 4; 2 | — |
| SECONDARY Median Survival Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood |
20.5; 8.0 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- 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 = = 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
Data sourced from ClinicalTrials.gov (NCT01557959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.