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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Colorectal Adenocarcinoma

Intervention / Treatment
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* Drug: S-8184 Paclitaxel Injectable Emulsion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: S-8184 Paclitaxel Injectable Emulsion|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the Objective Response Rate |  | When all patients have completed treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine time to disease progression |  | When all patients have completed treatment |