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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 Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor 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 website 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 take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like 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 access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes 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. Human subjects often obtain the finest healthcare possible for their Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern 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. Study of Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer
2. An Open Label Study of a Peptide Vaccine in Patients with Stage IIb or IIIa Non-Small Cell Lung Cancer
3. OSI-774 (Tarceva) in Treating Patients with Stage III or Stage IV Non-Small Cell Lung Cancer
4. Phase II Neoadjuvant Trial of a Continuous Infusion of Paclitaxel Plus Cisplatin Followed by Chest Radiotherapy for Patients with Stage III Non-Small Cell Lung Cancer
5. Utility of Anatometabolic Imaging for Radiation Treatment Planning for Lung Cancer
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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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