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Bevacizumab and PEG-Interferon alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors 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 and PEG-Interferon alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Bevacizumab and PEG-Interferon alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors Clinical research trials and Bevacizumab and PEG-Interferon alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors 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 and PEG-Interferon alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors. Bevacizumab and PEG-Interferon alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors 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 and PEG-Interferon alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors clinical trial. Test subjects typically receive the most expert healthcare available for their Bevacizumab and PEG-Interferon alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors 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 and PEG-Interferon alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors  Bevacizumab and PEG-Interferon alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors
Bevacizumab and PEG-Interferon alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors
For Condition: metastatic gastrointestinal carcinoid tumor,recurrent gastrointestinal carcinoid tumor,regional gastrointestinal carcinoid tumor
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them. PEG-interferon alfa-2b may stop the growth of cancer by stopping blood flow to the tumor. Combining bevacizumab with PEG-interferon alfa-2b may kill more cancer cells. PURPOSE: Randomizedphase II trial to study the effectiveness of combining bevacizumab with PEG-interferon alfa-2b in treating patients who have metastatic or unresectablecarcinoid tumors.
Details: OBJECTIVES: - Determine the progression-free survival rate in patients with metastatic or unresectable carcinoid tumors treated with bevacizumab and PEG-interferon alfa-2b. - Determine the tumor response rate (complete and partial) in patients treated with this regimen. - Determine the biochemical response rate of patients treated with this regimen. - Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients. OUTLINE: This is a randomized study. Patients are treated in 2 stages. - Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive bevacizumab IV on day 1. - Arm II: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1, 8, and 15. In both arms, courses repeat every 3 weeks. Patients with progressive disease at 9 weeks proceed to stage II. All other patients proceed to stage II after 18 weeks on stage I. - Stage II: Patients receive bevacizumab IV on day 1 and PEG-interferon alfa-2b SC once weekly. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) and remain in CR for 2 additional courses come off study. Patients are followed for survival. PROJECTED ACCRUAL: A total of 44 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 confirmed carcinoid tumor - Metastatic or unresectable local-regional disease - Measurable disease - No osseous metastasis as the only site of disease - No history or clinical evidence of CNS disease (e.g., primary brain tumor or any brain metastasis) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-2 OR - Karnofsky 70-100% Life expectancy - At least 12 weeks Hematopoietic - See Immunologic - Absolute granulocyte count > 1,500/mm^3 - Platelet count > 100,000/mm^3 - Hemoglobin > 8 g/dL - No bleeding diathesis or coagulopathy - No hemoglobinopathies (e.g., thalassemia) or any other cause of hemolytic anemia Hepatic - Bilirubin < 1.5 mg/dL - INR < 1.5 (if receiving warfarin) - No evidence of decompensated liver disease (e.g., ascites, bleeding varices, or spontaneous encephalopathy) Renal - Creatinine < 1.5 mg/dL - No baseline proteinuria - Patients with proteinuria ( 2+ or 100 mg/dL on urinalysis) are allowed provided 24-hour urinary protein is < 500 mg Cardiovascular - No clinically significant cardiovascular disease - No prior myocardial infarction - No uncontrolled hypertension - No New York Heart Association grade II-IV congestive heart failure - No serious cardiac arrhythmia requiring medication - No unstable angina - No grade II or greater peripheral vascular disease within the past year - No history of stroke Pulmonary - No chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) - No documented pulmonary hypertension Immunologic - None of the following immunologically mediated diseases: - Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) - Rheumatoid arthritis - Idiopathic thrombocytopenia purpura - Systemic lupus erythematosus - Autoimmune hemolytic anemia - Scleroderma - Severe psoriasis - No serious concurrent infections - No active infection requiring parental antibiotics on day 0 - No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies - No known hypersensitivity to interferon alfa or to any excipient or vehicle included in its formulation or delivery system Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No significant traumatic injury within the past 4 weeks - No preexisting thyroid abnormality for which thyroid function can not be normalized by medication - No concurrent nonmalignant uncontrolled medical illness or one whose control may be jeopardized by the complications of this study therapy - No uncontrolled psychiatric disorder - No psychiatric disorders that would preclude study compliance - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No serious nonhealing wound ulcer or bone fracture - No seizures not controlled with standard medical therapy PRIOR CONCURRENT THERAPY: Biologic therapy - Prior immunotherapy allowed - No prior interferon - No concurrent immunotherapy Chemotherapy - At least 4 weeks since prior chemotherapy, including radiosensitizers - No more than 1 prior chemotherapy regimen, including radiosensitizers - No concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior radiotherapy - Prior radiotherapy must not have contained the single evaluable lesion of this study in a radiation field - No concurrent radiotherapy Surgery - At least 4 weeks since prior major surgery or open biopsy (1 week for minor surgery) and recovered Other - No concurrent or recent full-dose anticoagulants or thrombolytic agents (except as required to maintain patency of preexisting, permanent indwelling IV catheters) - No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesYao, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting James Yao 713-792-2828
Additional Information:
Study ID Numbers: CDR0000271225; NCI-4772,MDA-ID-02063
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055809
Other Recurrent Gastrointestinal Carcinoid Tumor Studies:
1. Bevacizumab and PEG-Interferon alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors
Related Studies:
Other recurrent gastrointestinal carcinoid tumor Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Bevacizumab and PEG-Interferon alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors
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