PHASE II STUDY OF BROSTALYCIN (PNU-166196A) IN PATIENTS WITH NON-SMALL CELLULAR PULMON CANCER (NSCLC) ADVANCED, REFRACTORY OR RESISTANT TO PLATINUM-BASED CHEMOTHERAPY

Not Applicable

• Conditions: C349; -C349 Bronchus or lung, unspecified; Bronchus or lung, unspecified

• Registration Number: PER-010-02
• Lead Sponsor: PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-01-14
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Patients must have a diagnosis of NSCLC demonstrated histologically or cytologically, indicating that they are at the locally advanced stage of metastasis (stage IIIB or IV), which was refractory or resistant to a previous therapy based on platinum.
• Patients must have a disease that does not require surgery or radiation or a combined form of therapy for healing purposes. Palliative irradiation is allowed, as long as it is not applied to the white lesion (s).
• Patients must be ^ 18 years of age.
• Patients must have a performance status on the ECOG scale, <2.
• Patients must have a life expectancy of more than 3 months.

Exclusion Criteria

1. Concomitant treatment with any other agent in the Research phase.
Patients who have received more than one chemotherapy regimen for NSCLC, either as adjuvant / neoadjuvant therapy or as a treatment for locoregional or stage IV disease.
3. Known leptomeningeal or cerebral disease (documented by computed tomography [CT] or by magnetic resonance imaging (MRI) of the brain, required only in case of clinical suspicion of central nervous system [CNS] involvement).
4. Patients with previous malignancies (in the last 5 years) or current ones in other sites.
5. Patients who have previously received high doses of chemotherapy, with support from bone marrow cells or progenitor cells.
6. Patients who have received irradiation in 25% of their bone marrow.

Study & Design

• Study Type: Interventional
• Study Design: Not specified