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| Sponsored by: |
OncoGenex Pharmaceuticals |
| Information provided by: | OncoGenex Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00034151 |
Purpose
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 platinum resistant ovarian cancer or primary peritoneal carcinoma.
| Condition | Intervention | Phase |
|
Ovarian Cancer |
Drug: S-8184 Paclitaxel Injectable Emulsion |
Phase II |
| MedlinePlus related topics: | Cancer Ovarian Cancer |
| Drug Information available for: | Paclitaxel |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase IIA Evaluation of Safety and Efficacy of Weekly S-8184 Paclitaxel Injectable Emulsion in Second Line Treatment of Stage III or IV Platinum Resistant Ovarian Cancer or Primary Peritoneal Carcinoma |
| Enrollment: | 52 |
| Study Start Date: | March 2002 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
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
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologic diagnosis of ovarian cancer or primary peritoneal carcinoma
Stage III or IV disease
One and only one prior cytotoxic chemotherapy regimen which must have included a platinum agent
Platinum resistant disease, defined as documented progression within six months of completion of first line therapy
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 or clinically evaluable 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
Contacts and Locations More Information
| Responsible Party: | OncoGenex Pharmaceuticals ( Monica Krieger, VP Regulatory Affairs ) |
| Study ID Numbers: | SON-8184-1061 |
| First Received: | April 23, 2002 |
| Last Updated: | November 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00034151 |
| Health Authority: | United States: Food and Drug Administration |
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