Safety and Efficacy of S-8184 in Second Line Treatment of Relapsed Stage IIIB or IV Non Small Cell Lung Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal