|
Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity Clinical research trials and Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity. Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity clinical trial. Human subjects frequently get the finest healthcare available for their Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity  Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity
Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity
For Condition: Liver Cancer,Pancreatic Cancer,Gastrointestinal Cancer,Female Reproductive Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Kaplan Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of aminocamptothecin in treating patients with advanced cancer of the peritoneal cavity.
Details: OBJECTIVES: I. Determine the qualitative and quantitative toxicities of intraperitoneal aminocamptothecin colloidal dispersion administered every 28 days in 6 applications over a 12 day period in patients with advanced cancer confined to the peritoneal cavity. II. Determine the maximum tolerated dose of aminocamptothecin colloidal dispersion on this novel schedule in this patient population. III. Obtain pharmacological and biochemical data as potential predictors of responses and/or drug toxicities in these patients. IV. Document the presence and degree of antitumor activity of this regimen in this patient population. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive intraperitoneal aminocamptothecin colloidal dispersion (9-AC) over 30-60 minutes in 6 applications over a 12 day period (days 1, 3, 5, 8, 10, and 12). Courses are repeated every 28 days. Treatment continues for 4-6 courses in the absence of unacceptable toxic effects or disease progression. The dose of 9-AC is escalated in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed until death. PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional,�Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed advanced malignancy involving the peritoneal cavity, excluding leukemia and lymphoma; Patients with ovarian cancer must have received prior standard therapy - Predominantly small tumor metastases less than 1.0 cm in diameter including: Ovarian cancer with epithelial histology; Other gynecological tumors; Breast cancer; Gastric cancer; Colorectal cancer; Appendiceal cancer; Pancreatic cancer; Unknown primary cancer; Other malignancies with predominantly intraperitoneal manifestation - No extensive intraperitoneal adhesions that cannot be easily lysed laparoscopically or by laparotomy - No symptomatic disease outside the peritoneal cavity - Asymptomatic disease outside the peritoneum considered (e.g., bone lesions) --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and/or mitomycin) - Endocrine therapy: Not specified - Radiotherapy: At least 3 weeks since prior radiotherapy - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2.0 mg/dL; AST no greater than 2 times upper limit of normal - Renal: Creatinine no greater than 2.0 mg/dL - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrancoMuggia, Study Chair, Kaplan Cancer Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: CDR0000066605; NYU-9753,NCI-T97-0123
Study Start Date: August 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003548
Other Gastrointestinal Cancer Studies:
1. Gene Therapy in Treating Patients With Cancer
2. Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors
3. Vaccine Therapy with Tumor Specific Mutated P53 or Ras Peptides Alone or in Combination with Cellular Immunotherapy with Peptide Activated Lymphocytes (PAL Cells) Along with Subcutaneous IL-2
4. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
5. A Randomized, Phase II, Study of TNFerade™ Biologic with 5-FU and Radiation Therapy for first-line treatment of Unresectable, Locally Advanced Pancreatic Cancer.
Related Studies:
Other Gastrointestinal Cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity
|
|
|
|
|
|
|
|
