Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Lung Adenosquamous Cell Lung Cancer Bronchoalveolar Cell Lung Cancer Large Cell Lung Cancer Non-small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Squamous Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer |
Drug: cisplatin Biological: pegfilgrastim Drug: erlotinib hydrochloride Other: laboratory biomarker analysis Genetic: polymorphism analysis Other: pharmacogenomic studies Genetic: genetic linkage analysis Drug: docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Sequential Dose-Dense Chemotherapy and Dose-Intense Erlotinib for the Initial Treatment of Advanced Non-Small Cell Lung Cancer |
- Time to progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]Determined using Response Evaluation Criteria in Solid Tumors (RECIST). Estimated using the Kaplan-Meier method. Log-rank tests will be used to test for differences and Cox proportional hazards regression modeling will be used to adjust for patient demographics and characteristics such as smoking status at baseline (actively/non-actively smoking).
- Time to progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]Determined using RECIST. Estimated using the Kaplan-Meier method. Log-rank tests will be used to test for differences and Cox proportional hazards regression modeling will be used to adjust for patient demographics and characteristics such as smoking status at baseline (actively/non-actively smoking).
- Response rate among subgroups of patients according to molecular profiles including tumor characteristics and genetic polymorphisms from peripheral blood [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Response rate among subgroups of patients according to molecular profiles including tumor characteristics and genetic polymorphisms from peripheral blood [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Median survival among subgroups of patients according to molecular profiles including tumor characteristics and genetic polymorphisms from peripheral blood [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Median survival among subgroups of patients according to molecular profiles including tumor characteristics and genetic polymorphisms from peripheral blood [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | July 2007 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (chemo, chemoprotection, antiangiogenesis therapy)
Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
|
Drug: cisplatin
Given IV
Other Names:
Biological: pegfilgrastim
Given SC
Other Names:
Drug: erlotinib hydrochloride
Given PO
Other Names:
Other: laboratory biomarker analysis
Optional correlative study
Genetic: polymorphism analysis
Correlative study
Other: pharmacogenomic studies
Correlative study
Other Name: Pharmacogenomic Study
Genetic: genetic linkage analysis
Correlative study
Other Name: linkage analysis
Drug: docetaxel
Given IV
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine if this regimen improves the time-to-progression for patients with advanced non-small cell lung cancer (NSCLC) compared to historical controls.
SECONDARY OBJECTIVES:
I. To assess response rate and median survival. II. To evaluate tumor biomarkers that could predict response and survival for patients treated with this regimen including endothelial growth factor receptor (EGFR) expression, EGFR Fluorescence in situ hybridization (FISH), and k-ras mutations.
III. To evaluate genetic polymorphisms as markers of response and survival for patients treated with this regimen including polymorphisms in XPD, XRCC1, XRCC3, and cyclin D1.
OUTLINE:
Patients receive docetaxel intravenously (IV) over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive erlotinib hydrochloride orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and every 6 months for 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 =< 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
Exclusion Criteria:
- 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
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | William Petty | Wake Forest University |
More Information
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01557959 History of Changes |
| Other Study ID Numbers: | CCCWFU 62107, NCI-2009-01252 |
| Study First Received: | February 14, 2012 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Adenocarcinoma Adenocarcinoma, Mucinous Adenocarcinoma, Bronchiolo-Alveolar Lung Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Lung Diseases Respiratory Tract Diseases Docetaxel Cisplatin Erlotinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013