Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Ovarian Cancer

NCT00034151 | Completed Phase 2

• 1 other identifier: SON-8184-1061
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Determine the objective and partial response rates

  No time frame-based on number of patients

Secondary Outcomes (1)

• Time to progression, duration of response and duration of survival

  Based on number of patients

Interventions

S-8184 Paclitaxel Injectable Emulsion DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

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

Sponsors & Collaborators

• Achieve Life Sciences: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

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 24, 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