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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Adenocarcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the Objective Response Rate

Outcome Time Frame:

When all patients have completed treatment

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

SON-8184-1066

NCT ID:

NCT00034190

Start Date:

March 2002

Completion Date:

September 2007

Related Keywords:

  • Colorectal Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms

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