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Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma Clinical research trials and Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma. Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma clinical trial. Participants frequently obtain the most expert healthcare available for their Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.

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Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma



Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma

For Condition: Colorectal Adenocarcinoma
Status: Completed
Sponsor(s): Sonus Pharmaceuticals ,
Synopsis: Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients with stage III or IV colorectal adenocarcinoma.
Details: The goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of S-8184 in this patient population.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Histologic diagnosis of colorectal adenocarcinoma Stage III or IV (Dukes’s stage C or D) One and only one prior cytotoxic chemotherapy regimen which must have included 5-FU Adult (18 years of age or older) patients Adequate hematologic function (ANC greater than 1500 cells/mm3 and platelets greater than 100,000/mm3) Serum creatinine less than 2.0 mg/dL Total bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 3 times the upper limit of institutional normal values ECOG performance status of 0 - 2 Bidimensional measurable disease Patients who have signed an IRB / Ethics Committee approved informed consent Life expectancy at least 12 weeks Patient has fully recovered from any previous surgery (at least 4 weeks since major surgery) Patient has a negative pregnancy test prior to study entry if premenopausal. (Patients of child bearing potential must use a medically effective form of contraception during the treatment.) Exclusion Criteria: Patients who have received any taxane-containing preparation including Taxol (paclitaxel) or Taxotere (docetaxel) Females who are pregnant or lactating Patients with peripheral neuropathy NCI-CTC grade 2 or greater Patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry Patients who have had an investigational agent within 4 weeks of study entry Patients receiving concurrent anticonvulsants known to induce P450 isoenzymes
Total Enrollment: 

Location and Contact Information:

5 Clinical Sites
3 Cities,  , 
Russian Federation
 


Additional Information:
Study ID Numbers:
  SON-8184-1066; 
Study Start Date: March 2002
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034190

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