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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00792701 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with cisplatin works in treating patients with stage I non-small cell lung cancer that was removed by surgery.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: observation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II ERCC1 and RRM1-Based Adjuvant Therapy Trial in Patients With Stage I Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 55 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: No Intervention
Patients undergo active monitoring after surgery with disease assessments at 8, 16, and 24 weeks.
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Procedure: observation
Patients undergo active monitoring
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Arm II: Experimental
Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
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Drug: cisplatin
Given IV
Drug: gemcitabine hydrochloride
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients are assigned to 1 of 2 treatment arms based on RRM1 and ERCC1 gene expression.
Tumor samples acquired at the time of surgery are analyzed by immunofluorescence-based automated quantitative analysis for in situ expression of RRM1 and ERCC1. If available, additional samples are assessed using RT-PCR and real-time quantitative PCR for RRM1 and ERCC1 expression levels; polymorphism analysis for RRM1 and ERCC1 expression at the protein level; and tissue microarray analysis of genes associated with DNA synthesis, damage repair, and drug efficacy.
After completion of study therapy, patients are followed every 6 months for up to 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Completely resected (R0) disease by lobectomy, bilobectomy, or pneumonectomy performed by open thoracotomy or video-assisted thoracoscopic surgery within the past 35 days
PATIENT CHARACTERISTICS:
No other prior malignancy except for the following:
PRIOR CONCURRENT THERAPY:
No other concurrent investigational agents, chemotherapeutic agents, RT, or hormonal therapy
United States, Illinois | |
Decatur Memorial Hospital Cancer Care Institute | Recruiting |
Decatur, Illinois, United States, 62526 | |
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care 217-876-6601 | |
United States, Kansas | |
Tammy Walker Cancer Center at Salina Regional Health Center | Recruiting |
Salina, Kansas, United States, 67401 | |
Contact: William F. Cathcart-Rake, MD 785-452-4860 | |
United States, Massachusetts | |
Caritas St. Elizabeth's Medical Center | Recruiting |
Brighton, Massachusetts, United States, 02135-2997 | |
Contact: Paul J. Hesketh, MD 617-789-2317 | |
United States, Montana | |
Billings Clinic - Downtown | Recruiting |
Billings, Montana, United States, 59107-7000 | |
Contact: Clinical Trials Office - Billings Clinic - Downtown 800-996-2663 research@billingsclinic.org | |
Bozeman Deaconess Cancer Center | Recruiting |
Bozeman, Montana, United States, 59715 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 | |
Guardian Oncology and Center for Wellness | Recruiting |
Missoula, Montana, United States, 59804 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 | |
Community Medical Center | Recruiting |
Missoula, Montana, United States, 59801 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 | |
Glacier Oncology, PLLC | Recruiting |
Kalispell, Montana, United States, 59901 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 | |
Great Falls Clinic - Main Facility | Recruiting |
Great Falls, Montana, United States, 59405 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 | |
CCOP - Montana Cancer Consortium | Recruiting |
Billings, Montana, United States, 59101 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 | |
Hematology-Oncology Centers of the Northern Rockies - Billings | Recruiting |
Billings, Montana, United States, 59101 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 | |
Kalispell Medical Oncology at KRMC | Recruiting |
Kalispell, Montana, United States, 59901 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 | |
Kalispell Regional Medical Center | Recruiting |
Kalispell, Montana, United States, 59901 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 | |
Recruiting | |
Great Falls, Montana, United States, 59405 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 | |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Recruiting |
Missoula, Montana, United States, 59807 | |
Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick 406-329-7029 | |
Montana Cancer Specialists at Montana Cancer Center | Recruiting |
Missoula, Montana, United States, 59807-7877 | |
Contact: Clinical Trials Office - Montana Cancer Specialists at Montana 406-238-6962 | |
Northern Montana Hospital | Recruiting |
Havre, Montana, United States, 59501 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 | |
Northern Rockies Radiation Oncology Center | Recruiting |
Billings, Montana, United States, 59101 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 | |
St. James Healthcare Cancer Care | Recruiting |
Butte, Montana, United States, 59701 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 | |
St. Vincent Healthcare Cancer Care Services | Recruiting |
Billings, Montana, United States, 59101 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 | |
United States, Wyoming | |
Welch Cancer Center at Sheridan Memorial Hospital | Recruiting |
Sheridan, Wyoming, United States, 82801 | |
Contact: Benjamin T. Marchello, MD 406-238-6290 |
Study Chair: | Ralph G. Zinner, MD | M.D. Anderson Cancer Center |
Investigator: | Eric Vallieres, MD, FRCSC | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus |
Study ID Numbers: | CDR0000625070, SWOG-S0720 |
Study First Received: | November 16, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00792701 |
Health Authority: | Unspecified |
stage I non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Anti-Infective Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |