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.
Sponsor:
Information provided by:
OncoGenex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00034164
First received: April 23, 2002
Last updated: June 2, 2009
Last verified: June 2009

April 23, 2002
June 2, 2009
April 2002
September 2007   (final data collection date for primary outcome measure)
To determine the objective response rate [ Time Frame: After all patients completed therapy ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00034164 on ClinicalTrials.gov Archive Site
To determine time to disease progression [ Time Frame: After all patients completed therapy ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of S-8184 in Second Line Treatment of Relapsed Stage IIIB or IV Non Small Cell Lung Cancer
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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
Drug: S-8184 Paclitaxel Injectable Emulsion
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
September 2007
September 2007   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00034164
SON-8184-1063
No
Monica Krieger, VP Regulatory Affairs, OncoGenex Pharmaceuticals
OncoGenex Pharmaceuticals
Not Provided
Not Provided
OncoGenex Pharmaceuticals
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP