Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT01557959 |
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Recruitment Status :
Completed
First Posted : March 20, 2012
Results First Posted : June 28, 2013
Last Update Posted : June 29, 2018
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| Condition or disease | Intervention/treatment | 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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 45 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Actual Study Start Date : | July 2007 |
| Actual Primary Completion Date : | February 2011 |
| Actual Study Completion Date : | February 2011 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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:
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- Time to Progression [ Time Frame: 2 years ]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). Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood [ Time Frame: 2 years ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Pre-specified that data is only presented for the subgroups "Low Cyclin D1" and "High Cyclin D1".
- Median Survival Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood [ Time Frame: 2 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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)
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557959
| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | William Petty | Wake Forest University Health Sciences |
| Responsible Party: | Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT01557959 |
| Obsolete Identifiers: | NCT00723138 |
| Other Study ID Numbers: |
CCCWFU 62107 NCI-2009-01252 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
| First Posted: | March 20, 2012 Key Record Dates |
| Results First Posted: | June 28, 2013 |
| Last Update Posted: | June 29, 2018 |
| Last Verified: | May 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Adenocarcinoma of Lung Adenocarcinoma, Bronchiolo-Alveolar Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Adenocarcinoma |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Docetaxel Erlotinib Hydrochloride Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Enzyme Inhibitors |