Expired Study
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Winston-Salem, North Carolina 27157


Purpose:

RATIONALE: 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 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 may kill more tumor cells. PURPOSE: This phase II trial is studying how well docetaxel given together with cisplatin and pegfilgrastim followed by erlotinib works in treating patients with stage IIIB or stage IV non-small cell lung cancer.


Study summary:

OBJECTIVES: Primary - To determine if dose-dense docetaxel, cisplatin, and pegfilgrastim followed by dose-intense erlotinib hydrochloride improves the time to progression in patients with stage IIIB or IV non-small cell lung cancer compared to historical controls. Secondary - To assess response rate and median survival. - To evaluate genetic polymorphisms as markers of response and survival, including polymorphisms in XPD, XRCC1, XRCC3, and cyclin D1, in patients treated with this regimen. OUTLINE: Patients receive docetaxel IV over 1 hour and 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. Blood is collected at baseline for pharmacogenetic studies. Samples are examined for genetic polymorphisms. After completion of study treatment, patients are followed every 3 months for 1 year and every 6 months for 2 years.


Criteria:

Inclusion: - Histologically or cytologically confirmed non-small cell carcinoma (NSCLC) including any of the following subtypes: - squamous carcinoma - basaloid carcinoma - adenocarcinoma - bronchioloaveolar carcinoma - adenosquamous carcinoma - large cell carcinoma (not neuroendocrine) - sarcomatoid carcinoma - non-small cell carcinoma not otherwise specified - Patients with previously completely resected disease must have histologically or cytologically documentation or recurrence. - Stage IIIB due to malignant pleural or pericardial effusion or stage IV disease. - Patients must be ineligible for Avastin or decline treatment with Avastin. - 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 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 - ECOG Performance Status 0-1. - Age ≥18 years. - Required Initial Laboratory Data: - Granulocytes ≥1,500/µl - Platelets ≥100,000/µl - Creatinine ≤ULN - Bilirubin ≤1.5 mg/dl - SGOT (AST) ≤1.5x ULN - Alk. phos. ≤2.5x ULN - Patients must provide verbal and written informed consent to participate in the study. Exclusion - 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.


NCT ID:

NCT00723138


Primary Contact:

Principal Investigator
W. Jeffrey Petty, MD
Comprehensive Cancer Center of Wake Forest University


Backup Contact:

N/A


Location Contact:

Winston-Salem, North Carolina 27157
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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