Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00034151
NCT00034151CompletedPhase 2

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

Achieve Life Sciences0 sites52 target enrollmentStarted: March 1, 2002Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
52
Primary Endpoint
Determine the objective and partial response rates
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 platinum resistant ovarian cancer or primary peritoneal carcinoma.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Determine the objective and partial response rates

Time Frame: No time frame-based on number of patients

Secondary Outcomes

  • Time to progression, duration of response and duration of survival(Based on number of patients)

Investigators

Sponsor Class
Industry

Similar Trials

Completed
Phase 2
Safety and Efficacy of S-8184 in Second Line Treatment of Relapsed Stage IIIB or IV Non Small Cell Lung CancerCarcinoma, Non-Small-Cell Lung
NCT00034164Achieve Life Sciences52
Completed
Phase 2
Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal AdenocarcinomaColorectal Adenocarcinoma
NCT00034190Achieve Life Sciences28
Completed
Phase 2
Safety and Efficacy of S-8184 in Treatment of Locally Advanced, Metastatic, or Recurrent TCC of the UrotheliumUrologic Neoplasms
NCT00034177Achieve Life Sciences27
Completed
Phase 1
Study with S 81694 in perfusion in patients with solid tumorsAdvanced/metastatic solid tumorsCancer
ISRCTN35641359Institut de Recherche Internationales Servier39
Completed
Phase 1
Study of the Efficacy, Safety, and Pharmacokinetics of SM88 in Patients With Prostate CancerRising Prostate Specific Antigen (PSA)Prostate Cancer
NCT02796898Tyme, Inc23