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Sponsored by: |
OncoGenex Pharmaceuticals |
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Information provided by: | OncoGenex Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00034164 |
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 relapsed stage IIIB or IV non small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Non-Small-Cell Lung |
Drug: S-8184 Paclitaxel Injectable Emulsion |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 Relapsed Stage IIIB OR IV Non Small Cell Lung Cancer |
Enrollment: | 52 |
Study Start Date: | April 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologic diagnosis of non small cell lung cancer
Relapsed or unresectable stage IIIB or IV disease
One and only one prior cytotoxic chemotherapy regimen which must have included a platinum agent dosed at 60 mg/m2 or higher per cycle for cisplatin and AUC 6 per cycle for carboplatin
Documented response of at least stable disease while on 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)
Patients with intracranial metastases having neurologic function stabilized for less than 4 weeks prior to study entry
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
Responsible Party: | OncoGenex Pharmaceuticals ( Monica Krieger, VP Regulatory Affairs ) |
Study ID Numbers: | SON-8184-1063 |
Study First Received: | April 23, 2002 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00034164 |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |