|
Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer Clinical research trials and Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer. Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer  Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
For Condition: Rectal Cancer,Colon Cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as epothilone D work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of epothilone D as second-line therapy in treating patients who have advanced or metastaticrefractorycolorectal cancer.
Details: OBJECTIVES: Primary - Determine the antitumor activity of epothilone D as second-line treatment, in terms of objective response rate, in patients with advanced or metastatic refractory colorectal cancer. Secondary - Determine the safety of this drug in these patients. - Determine the response duration in patients responding to treatment with this drug. - Determine time to tumor progression and overall survival in patients treated with this drug. - Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 19-69 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 or cytologically confirmed advanced or metastatic adenocarcinoma of the colon or rectum - Evidence of at least 1 site of unidimensionally measurable disease by radiography or physical examination - Failed 1 prior treatment with a fluoropyrimidine in combination with either irinotecan OR oxaliplatin for advanced or metastatic disease - No known CNS metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Hemoglobin 9 g/dL - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - Bilirubin 1.5 times upper limit of normal (ULN) - AST and ALT 2.5 times ULN (5 times ULN if hepatic metastases are present) - Alkaline phosphatase 5 times ULN Renal - Creatinine 1.5 times ULN Cardiovascular - No New York Heart Association class III or IV congestive heart failure - No QTc > 450 msec for males or > 470 msec for females - No personal or family history of congenital long QT syndrome Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - No pre-existing neuropathy grade 2 or greater - No documented grade 3 or 4 hypersensitivity reaction to prior therapy containing Cremophor - No infection requiring parenteral or oral anti-infective treatment - No altered mental status or psychiatric condition that would preclude giving informed consent - No other medical condition that would preclude study participation - No other malignancy within the past 5 years except cured basal cell skin cancer, carcinoma in situ of the cervix or bladder, or stage T1 or T2 prostate cancer with a prostate-specific antigen < 2 ng/mL PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent sargramostim (GM-CSF) - No concurrent routine prophylactic use of filgrastim (G-CSF) Chemotherapy - See Disease Characteristics - At least 3 weeks since prior chemotherapy and recovered Endocrine therapy - Not specified Radiotherapy - At least 3 weeks since prior radiotherapy and recovered Surgery - At least 3 weeks since prior surgery and recovered Other - More than 3 weeks since prior investigational agents (therapeutic or diagnostic) - No other concurrent therapy for advanced or metastatic colorectal cancer - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeonardSaltz, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Ghassan Abou-Alfa 212-639-3112
Additional Information:
Study ID Numbers: CDR0000350080; ROCHE-NO17320,MSKCC-03113
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077259
Other Colon Cancer Studies:
1. Leucovorin and Fluorouracil With or Without Oxaliplatin Compared to Capecitabine With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
2. Genetic Study of Young Patients With Colorectal Cancer
3. Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
4. Genetic Study of Patients and Families With a History of Colorectal Cancer
5. Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps
Related Studies:
Other Colon Cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
|
|
|
|
|
|
|
|
