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Safety and Efficacy of S-8184 in Second Line Treatment of Relapsed Stage IIIB or IV Non Small Cell Lung Cancer
This study has been completed.
Sponsored by: OncoGenex Pharmaceuticals
Information provided by: OncoGenex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00034164
  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 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

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources
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

Further study details as provided by OncoGenex Pharmaceuticals:

Primary Outcome Measures:
  • To determine the objective response rate [ Time Frame: After all patients completed therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine time to disease progression [ Time Frame: After all patients completed therapy ] [ Designated as safety issue: No ]

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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034164

Locations
Russian Federation
3 cities, Russian Federation
Sponsors and Collaborators
OncoGenex Pharmaceuticals
  More Information

sponsor's home page  This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009