|
Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer 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 Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer conditions. Clinical Trials Search.org is a site dedicated 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 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 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 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 Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer 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.
|
|
|
|
|
|
|
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. Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis.
2. Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver
3. Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Colorectal Cancer
4. High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed
5. Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin
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
|
|
|
|
|
|
|
|
