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Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients Clinical research trials and Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients. Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients clinical trial. Participants typically obtain the most effective healthcare available for their Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients  Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients
Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients
For Condition: Carcinoma, Squamous Cell,Carcinoma, Non-Small-Cell Lung,Lung Neoplasms
Status: Completed
Sponsor(s): M.D. Anderson Cancer Center , Genentech,Vanderbilt-Ingram Cancer Center
Synopsis: Patients will be treated with oral Tarceva daily for 21 days each cycle. Patients will receive Avastin by IV on day 1 of each 21-day cycle. If a patient has no grade 3 or 4 toxicities after the 1st cycle, then the patient may continue the same doses of Tarceva and Avastin for another cycle. If the patient has response or stable disease after 6 weeks (2 cycles), the patient may continue on the same doses of Tarceva and Avastin. A patient may receive treatment on this study for up to one year, unless his or her disease progresses or side effects become too severe. The starting dose is 100 mg daily of Tarceva and 7.5 mg/kg every 21 days of Avastin.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion: - Patient has histologically proven stage IIIB with pleural effusion, stage IV or recurrent non-squamous NSCLC. - Patient has a Karnofsky performance status >=70%. - Patient has adequate bone marrow function: WBC >= 3,000 cells/mm3, ANC >= 1,500 cells/mm3, platelet count >= 100,000 cells/mm3, Hgb >= 9.0 g/dL. - Patient has adequate liver function: total bilirubin level <= 2.0 mg/dL, albumin >= 2.5 g/dL. - Transaminases (SGOT and/or SGPT) and alkaline phosphatase may be up to 2.5 x ULN. - Patient has adequate renal function: a serum creatinine < 2 mg/dl - Patient has signed a written informed consent. - Patient has received at least one prior chemotherapeutic regimen for recurrent or metastatic disease. Exclusion: - Patient has not received prior chemotherapeutic regimens for advanced disease. - Patient has received prior biologic therapy targeting EGFR and/or VEGF. - Patient has received radiation therapy within the past 3 weeks. - Patient has signs or symptoms of acute infection requiring systemic therapy. - Patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent. - Patient requires total parenteral nutrition with lipids. - Patient has a history of uncontrolled heart disease and/or uncontrolled hypertension (> 150/100 mmHg). - Because of the possible teratogenic effect, pregnant women and women who are currently breast-feeding may not participate in this study. - All women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrolling in the study. - Serious infection or other intercurrent illness requiring immediate therapy. - Clinical/imaging evidence of CNS malignancy or with recently treated CNS malignancy, as well as those experiencing recent CVA or other CNS bleeding. - Pediatric patients in whom open growth plates would be expected. - Urine protein qualitative value of > 30 in urinalysis or > +1 in proteinuria testing by dipstick. - Patient has a clinical history of coagulopathy or thrombosis. - Patient is currently receiving or intending to receive anti-coagulants. - Patient has had a recent myocardial infarction (still inside the healing period). Note: a six-month window is optimal. - Patient is recovering from recent major surgery (e.g., less than 2 weeks since surgery) or is anticipating major surgery. - Patient has a clinical history of hemoptysis or hematemesis. - Patient may not have PEG or G tube.
Total Enrollment: 48
Location and Contact Information:
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: ID01-604; VICC THO 0206
Study Start Date: August 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043823
Other Carcinoma, Squamous Cell Studies:
1. An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck
2. Study Of Zd1839 (Iressa™) Versus Methotrexate For Previously Treated Patients With Squamous Cell Carcinoma Of The Head And Neck
3. Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients
4. Effectiveness and Safety of INGN 201 in Combination with Chemotherapy Versus Chemotherapy Alone
5. Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy
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Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients
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