|
Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction Clinical research trials and Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction. Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction clinical trial. Subjects typically recieve the finest healthcare available for their Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction  Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction
Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction
For Condition: Gastroesophageal Cancer,Cancer of Stomach
Status: Recruiting
Sponsor(s): Enzon ,
Synopsis: The purpose of this study is to evaluate the safety and efficacy of pegamotecan (PEG-camptothecin) in patients with pathologically-diagnosed locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction who have relapsed or progressed following one prior chemotherapy treatment regimen.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Pathologically confirmed diagnosis of adenocarcinoma of the stomach or gastroesophageal junction. - Disease measurable in at least one dimension. - Target tumors outside of prior radiation field(s). - An Eastern Cooperative Oncology Group (ECOG) performance scale score of 0 or 1 - Adequate hemotologic profile, as determined by hemoglobin, platelet, and neutrophil count. - Adequate renal function, as determined by serum creatinine and serum albumin measurements. - Adequate liver function, as determined by total bilirubin and transaminases levels. Transaminases may be <= 5.0x ULN if due to metastatic disease in the liver. - Fully recovered from prior surgery. - No history of hemorrhagic cystitis. - No microscopic hematuria (>10 RBC/hpf) unless documented to be due to an infection or non-bladder origin. - Capable of understanding the protocol requirements and risks and providing written informed consent. Exclusion Criteria: - Concurrent serious medical illness unrelated to tumor within the past 6 months. - Known chronic infectious disease, such as AIDS or hepatitis (screening for hepatitis and HIV will not be performed). - Positive screening pregnancy test or is breast-feeding. - Female or male subject of reproductive capacity who is unwilling to use methods appropriate to prevent pregnancy during the course of this study. - Receiving concurrent chemotherapy, investigational agents, radiotherapy, surgery, or has received wide field radiation within the previous 4 weeks. - History of another malignancy (except basal and squamous cell carcinomas of the skin and carcinoma in situ of the cervix) within the last 5 years. - Known or clinically suspected brain metastases. - Received more than one prior regimen of chemotherapy for locally advanced or metastatic adenocarcinoma of the stomach or GE junction. - Received prior neoadjuvant and/or adjuvant cytotoxic chemotherapy - Received any investigational drug within the last 30 days. - Not fully recovered from any prior, and from any reversible side effects related to the administration of cytotoxic chemotherapy, investigational agents, or radiation therapy. - Prior treatment with a camptothecin analog.
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: CAM-9011;
Study Start Date: December 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080002
Other Cancer Of Stomach Studies:
1. Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction
Related Studies:
Other Cancer of Stomach Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction
|
|
|
|
|
|
|
|
