Phase I/II study of inhaled doxorubicin combined with platinum-based therapy for advanced non-small cell lung cancer.

Purpose: We have shown the feasibility of administering inhaled doxorubicin to patients with cancer. This study evaluated inhaled doxorubicin combined with cisplatin and docetaxel in patients with non-small cell lung cancer. The principal objective was to determine safety and, secondarily, efficacy.

Phase II study of cisplatin plus etoposide and bevacizumab for previously untreated, extensive-stage small-cell lung cancer: Eastern Cooperative Oncology Group Study E3501.

Purpose: To investigate the efficacy and safety of bevacizumab plus cisplatin and etoposide in patients with extensive-stage disease, small-cell lung cancer (ED-SCLC).

Patients And Methods: In this phase II trial, 63 patients were treated with bevacizumab 15 mg/kg plus cisplatin 60 mg/m(2) and etoposide 120 mg/m(2), which was followed by bevacizumab alone until death or disease progression occurred. The primary end point was the proportion of patients alive at 6 months without disease progression (ie, progression-free survival [PFS]).

Phase II trial of weekly docetaxel/irinotecan combination in advanced pancreatic cancer.

Background: Docetaxel and irinotecan have activity in pancreatic cancer. The combination of docetaxel and irinotecan is attractive because of preclinical evidence of synergy between the two drugs. We have previously demonstrated the safety of docetaxel 35 mg/m(2) and irinotecan 50 mg/m(2) given on days 1, 8, 15, and 21 of a 35-day schedule.

Phase I study of inhaled Doxorubicin for patients with metastatic tumors to the lungs.

Purpose: To evaluate the toxicity profile of inhalational doxorubicin in patients with malignant disease in the lung.

Experimental Design: The OncoMyst Model CDD-2a inhalation device aerosolizes compounds to particles of 2 to 3 mum and prevents exhaled aerosol from escaping into the environment. Deposition efficiency of inhaled Technetium 99m was used to predict deposition of doxorubicin and calculate dose.

Evaluation of irinotecan plus paclitaxel in patients with advanced non-small cell lung cancer.

Purpose: We conducted a phase II study to evaluate the efficacy and safety of the combination of irinotecan and paclitaxel in patients with advanced stage non-small cell lung cancer (NSCLC).

Patients And Methods: Patients were eligible if they had histologically confirmed chemotherapy naïve stage IV NSCLC or stage IIIB disease that was not suitable for combined modality therapy. Patients were treated with irinotecan 50 mg/m2 and paclitaxel 75 mg/m2 on days 1 and 8 of a 21-day cycle.

Progress in the therapy of small cell lung cancer.

Small cell lung cancer (SCLC) accounts for approximately 14% of all cases of lung cancer. Combination chemotherapy is the most effective treatment modality for SCLC and recently, several new active drugs have emerged. Combinations of platinum agents with CPT-11 or gemcitabine have been successfully compared in phase III trials against the cisplatin/etoposide standard.

A phase II study of topotecan and cyclophosphamide with G-CSF in patients with advanced small cell lung cancer.

Purpose: We conducted a multicenter phase II study to evaluate the efficacy and safety of the combination of topotecan and cyclophosphamide for patients with advanced small cell lung cancer (SCLC).

Patients And Methods: Patients were eligible if they had newly diagnosed extensive stage SCLC or if they had SCLC that progressed more than three months after completion of the first chemotherapy regimen. Patients were treated every 21 days with cyclophosphamide 600 mg/m2 IV on day 1 and topotecan 1.

Angiogenesis in non-small cell lung cancer. A new target for therapy.

Non-small cell lung cancer (NSCLC) is cured with surgery in a minority of affected persons. Chemotherapy and radiation can palliate and extend survival of patients with disease not amenable to surgery. Consequently, new treatment options are urgently needed.

Lapatinib ditosylate GlaxoSmithKline.

Lapatinib ditosylate, an ErbB-2 and EGFR dual tyrosine kinase inhibitor, is being developed by GlaxoSmithKline plc for the potential treatment of solid tumors.

Phase I dose escalation trial of weekly docetaxel plus irinotecan in patients with advanced cancer.

Background. Docetaxel and irinotecan have additive or synergistic activity in vitro and in vivo as well as differing toxicities and unique mechanisms of action. We conducted a phase I trial to determine the maximum-tolerated dose of docetaxel and irinotecan given on a weekly schedule.

Erlotinib OSI/Roche/Genentech.

Erlotinib (CP-358774, OSI-774, Tarceva), a quinazoline derivative, is an orally active epidermal growth factor receptor tyrosine kinase inhibitor under development jointly by Genentech, OSI (formerly Oncogene Science) and Roche, both as monotherapy and combination therapy for the potential treatment of solid tumors, including non-small-cell lung cancer (NSCLC) and pancreatic, breast, head and neck cancers [203487]. Development of the compound is most advanced for NSCLC and pancreatic cancer; in July 2001, phase III combination trials were initiated for NSCLC [416835]. In October 2001, phase III monotherapy trials in NSCLC and phase III combination trials in pancreatic cancer were also initiated [426704].

Camptothecin and taxane regimens for small-cell lung cancer.

For more than 2 decades, combination chemotherapy has been the standard treatment for patients with small-cell lung cancer. Despite high initial response rates in both extensive- and limited-stage disease, long-term survival rates are only 10% to 20%. Camptothecins and taxanes are newer classes of agents that have shown significant activity against small-cell lung cancer.

Phase I study of perillyl alcohol in patients with refractory malignancies.

We treated 21 patients in a dose-finding and pharmacokinetic study of the monoterpene perillyl alcohol with the drug given orally in 3 divided doses on a chronic basis. The average number of days that patients remained on study was 48 (range 11-172). Fatigue and low-grade nausea were dose limiting.

Therapy for stage IIIB and stage IV non-small cell lung cancer.

The treatment options for unresectable stage III NSCLC include definitive RT, chemotherapy, combined chemoradiotherapy, or supportive care. Compared with radiation alone or chemotherapy alone, the combination of chemotherapy and standard RT confers a modest survival benefit at the cost of increased toxicity for patients with an excellent performance status. For metastatic disease, combination chemotherapy--in particular, platinum-based regimens--improves symptom control and survival.