Overview

Safety and Efficacy of S-8184 in Second Line Treatment of Relapsed Stage IIIB or IV Non Small Cell Lung Cancer

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
All
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 relapsed stage IIIB or IV non small cell lung cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Achieve Life Sciences
OncoGenex Technologies
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
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