|
Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer Clinical research trials and Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer. Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer  Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
For Condition: stage 3A non-small cell lung cancer,bronchoalveolar cell lung cancer,adenocarcinoma of the lung,squamous cell lung cancer,large cell lung cancer,stage 3B non-small cell lung cancer
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and radiation therapy with combination chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining erlotinib and radiation therapy with combination chemotherapy in treating patients who have unresectablestage III non-small cell lung cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of erlotinib that can be administered with chest radiotherapy in combination with cisplatin and etoposide or carboplatin and paclitaxel in patients with inoperable stage III non-small cell lung cancer. - Determine the dose-limiting toxicity of these regimens in these patients. - Assess the clinical response (complete response, partial response, progressive disease, or stable disease) in patients treated with these regimens. - Determine levels of tumor epidermal growth factor expression in patients treated with these regimens. OUTLINE: This is a multicenter, dose-escalation study of erlotinib. Patients are assigned to 1 of 2 treatment groups. - Group 1: Patients receive cisplatin IV over 2 hours on days 1, 8, 29, and 36; etoposide IV over 1 hour on days 1-5 and 29-33; and oral erlotinib once daily on days 1-49. Patients undergo concurrent radiotherapy 5 days a week for 7 weeks beginning on day 1. Patients receive consolidation therapy comprising docetaxel IV over 1 hour on days 50, 71, and 92. Some patients may also receive oral erlotinib once daily on days 50-112. - Group 2: Patients receive induction chemotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21. Some patients may also receive oral erlotinib once daily on days 1-42. Patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 43, 50, 57, 64, 71, 78, and 85 and oral erlotinib once daily on days 43-91. Patients undergo radiotherapy concurrently with consolidation therapy 5 days a week for 7 weeks beginning on day 43. In both groups, cohorts of 3-6 patients receive escalating doses of erlotinib during concurrent chemoradiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 8 weeks. PROJECTED ACCRUAL: A total of 24-48 patients (12-24 per treatment group) will be accrued for this study within 6-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer - Squamous cell carcinoma - Adenocarcinoma (including bronchoalveolar) - Large cell carcinoma (including giant and clear cell carcinomas) - Stage IIIA (T1 or T2, N2) or IIIB disease not amenable to resection or surgery - T3, N2 or T4, N0-N2 disease also allowed if based on the closeness to the carina, invasion of the mediastinum, or invasion of the chest wall - T3, N0-N1 disease allowed provided the disease is not amenable for surgical resection - No M1 disease - No disease invasion of a vertebral body - Tumors adjacent to a vertebral body allowed provided all gross disease can be encompassed in the radiotherapy boost field and there is no bone invasion - Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in the radiotherapy boost field - Pleural effusion that is transudative, cytologically negative, and non-bloody allowed if the tumor can be encompassed in a reasonable field of radiotherapy - No exudative, bloody, or cytologically malignant effusions - Effusions present on CT scans but not on chest x-ray (CXR) and too small for thoracentesis are allowed - Measurable or evaluable disease - Pleural effusions are not considered measurable or evaluable - Measurable disease is defined as any mass in 2 perpendicular diameters by CXR, CT scan, or MRI - Evaluable disease includes lesions apparent on CXR or CT scan that are: - Ill-defined masses associated with post-obstructive changes - Mediastinal or hilar adenopathy measurable in only one dimension PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 OR - Karnofsky 70-100% Life expectancy - More than 6 months Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin normal - AST and ALT no greater than 1.5 times upper limit of normal (ULN) and alkaline phosphatase normal OR - AST and ALT normal and alkaline phosphatase no greater than 2.5 times ULN Renal - Creatinine normal OR - Creatinine clearance at least 50 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Ophthalmic - No history of cornea abnormalities (e.g., dry-eye syndrome, Sjögren's syndrome) - No congenital abnormality (e.g., Fuch's dystrophy) - No abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose) - No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) Gastrointestinal - No gastrointestinal tract disease resulting in the inability to take oral medications - No required IV alimentation - No peptic ulcer disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No history of allergy to compounds of similar chemical or biologic composition to erlotinib or other study agents - No significant traumatic injury within the past 21 days - No other uncontrolled concurrent illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No other active malignancy within the past 6 months except non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent colony-stimulating factors (filgrastim [G-CSF] or sargramostim [GM-CSF]) with radiotherapy Chemotherapy - No prior chemotherapy for lung cancer Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior chest radiotherapy Surgery - See Disease Characteristics - At least 7 days since prior mediastinoscopy - More than 3 weeks since prior formal exploratory thoracotomy - More than 3 weeks since prior major surgery - No prior surgical procedures affecting absorption Other - No prior epidermal growth factor receptor-targeting therapies - No other concurrent investigational or commercial agents or therapies directed at malignancy - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnnMauer, Study Chair, University of Chicago Cancer Research Center
Louis A. Weiss Memorial Hospital *Recruiting*
Chicago, Illinois, 60640
United States
Recruiting Stuart Krauss 773-878-8700
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting David Sciortino 219-484-8830
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting David Taber 574-234-5123
LaGrange Memorial Hospital *Recruiting*
LaGrange, Illinois, 60525
United States
Recruiting James Hannigan 708-579-3418
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Ann Mauer 773-702-4138
Ingalls Memorial Hospital *Recruiting*
Harvey, Illinois, 60426
United States
Recruiting Mark Kozloff 708-339-4800
Central Illinois Hematology Oncology Center *Recruiting*
Springfield, Illinois, 62701
United States
Recruiting Edem Agamah 217-525-2500
Oncology Care Associates, P.L.L.C. *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-985-0029
Additional Information:
Study ID Numbers: CDR0000069474; UCCRC-11432B,NCI-5411
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042835
Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
2. Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
3. Combination Chemotherapy Plus Radiation Therapy With or Without Gefitinib in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
4. Paclitaxel in Treating Patients With Lung Cancer
5. Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Related Studies:
Other stage 3B non-small cell lung cancer Clinical Trials
Other Illinois Clinical Trials
Other Harvey Clinical Trials
Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
|
|
|
|
|
|
|
|
