Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma
A Phase IIa Multicenter Evaluation of The Safety And Efficacy of Weekly Administration of S-8184 Paclitaxel Injectable Emulsion In Second Line Treatment of Patients With Stage III or IV Colorectal Adenocarcinoma
1 other identifier
interventional
28
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2002
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 23, 2002
CompletedFirst Posted
Study publicly available on registry
April 25, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedJune 4, 2009
June 1, 2009
5.5 years
April 23, 2002
June 2, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Determine the Objective Response Rate
When all patients have completed treatment
Secondary Outcomes (1)
To determine time to disease progression
When all patients have completed treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
5 Clinical Sites
3 Cities, Russia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 23, 2002
First Posted
April 25, 2002
Study Start
March 1, 2002
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
June 4, 2009
Record last verified: 2009-06