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Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer Clinical research trials and Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer. Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer  Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
For Condition: stage 1 non-small cell lung cancer,stage 2 non-small cell lung cancer,stage 3A non-small cell lung cancer
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy before surgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of bevacizumab, paclitaxel, and carboplatin given before surgery in treating patients who have stage IB, stage II, or stage IIIA non-small cell lung cancer.
Details: OBJECTIVES: - Determine the clinical complete and partial response rate in patients with stage IB, II, or IIIA resectable non-small cell lung cancer treated with neoadjuvant bevacizumab, paclitaxel, and carboplatin. - Determine the pathologic complete response rate in patients treated with this regimen. - Determine the ability to proceed with and complete a potentially curative resection in patients treated with this regimen. - Determine the safety and toxicity of this regimen in these patients. OUTLINE: Patients receive neoadjuvant bevacizumab IV over 60-90 minutes, paclitaxel IV over 3 hours, and carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo surgical resection within 4-6 weeks after completion of chemotherapy. Patients are followed within 3 months. PROJECTED ACCRUAL: A total of 23-39 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer - Stage IB (T2, N0), II (T1 or T2, N1 or T3, N0), or IIIA (T3, N1) - Potentially resectable disease - No large central primary tumors in proximity to significant blood vessels - No bronchoscopically evident endobronchial tumors - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 OR - Karnofsky 70-100% Life expectancy: - More than 12 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 - No history of an inherited bleeding disorder - No inherited predisposition to a hypercoagulable state - No clinically evident hypercoagulable state or bleeding diathesis Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - AST/ALT no greater than 2.5 times ULN - INR no greater than 1.5 - PTT no greater than 36 seconds Renal: - Creatinine less than 1.5 times ULN OR - Creatinine clearance at least 60 mL/min - No nephrotic syndrome - Urine protein no greater than 0.5 g/24 hours Cardiovascular: - No poorly controlled hypertension (greater than 150 mm Hg systolic and/or greater than 100 mm Hg diastolic) despite treatment - No uncompensated coronary artery disease - No history of myocardial infarction - No severe peripheral vascular disease - No inherited predisposition to thrombosis - No deep venous or arterial thrombosis - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Pulmonary: - No hemoptysis - No pulmonary embolism Other: - No history of allergic reactions to compounds of similar chemical or biologic composition to study drugs - No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No psychiatric illness or social situation that would preclude study compliance - No significant traumatic injury within the past 28 days - No uncontrolled concurrent illness - No ongoing or active infection - No serious, non-healing wound, ulcer, or bone fracture - No other active malignancy - No requirement for full-dose anticoagulation or thrombolytic therapy PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy for this cancer - No concurrent prophylactic growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF]) Chemotherapy: - No prior chemotherapy for this cancer - Prior chemotherapy for another malignancy allowed provided the prior malignancy was curatively treated and is currently controlled Endocrine therapy: - No prior endocrine therapy for this cancer Radiotherapy: - No prior radiotherapy for this cancer - Prior radiotherapy for another malignancy allowed provided the prior malignancy was curatively treated and is currently controlled - No concurrent radiotherapy Surgery: - Prior diagnostic bronchoscopy, mediastinoscopy, or CT-guided biopsy allowed - At least 28 days since prior major surgical procedure or open biopsy Other: - No other concurrent investigational agents - No other concurrent anticancer investigational or commercial agents or therapies - No concurrent combination antiretroviral therapy for HIV-positive patients - Concurrent low-dose warfarin for maintenence of preexisting, permanent, indwelling IV catheters allowed provided INR less than 1.5
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnnMauer, Study Chair, University of Chicago Cancer Research Center
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting Gregory Otterson 614-293-6786
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Ann Mauer 773-702-4138
Additional Information:
Study ID Numbers: CDR0000068956; NCI-2655,UCCRC-OSU-2001C0114,OSU-0120
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025389
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
2. Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
3. Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
4. Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
5. Acridine Carboxamide in Treating Patients With Advanced Non-small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
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