NCT01660399

Clinical Trial of Boanmycin Hydrochloride With Docetaxel for Patients With Lung Squamous Cell Cancer as Chemotherapy

Boanmycin Hydrochloride for Injection in Combination With Docetaxel for Patients With Advanced Lung Squamous Cell Carcinoma as Salvage Chemotherapy: a Prospective, Randomized, Parallel and Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This predictive, randomized, double-blind, multi-center trial is going to evaluate the efficacy and safety of two regimens of boanmycin plus docetaxel versus docetaxel alone as a second line treatment for chemotherapy for stage IIIb-IV or postoperative recurrent squamous cell lung cancer patients.

Detailed description

At present, there is no reliable second line treatment except chemotherapy for squamous cell carcinoma patients, the current chemotherapy regimen, including docetaxel as a single agent which is known as the gold standard, the weekly using of docetaxel and the combination of EGFR-TKI has few evidence for high response rates and prolonged survival.On the other hand, the adverse reaction of chemotherapy makes the combined chemotherapy cannot improve therapeutic effects. Boanmycin with special pharmacological basis, as well as the high purity, may not obvious increase in adverse reactions, and probably improve the effect of chemotherapy. At the same time, because of its low lung toxicity, especially in the combined use of corticosteroids, and in the background of the poor survival of advanced squamous cell lung cancer patients, the chemotherapy regimen of boanmycin plus docetaxel needs to be investigated. This predictive, randomized, double-blind, multi-center trial is going to evaluate the efficacy and safety of two regimens of boanmycin plus docetaxel versus docetaxel alone as a second line treatment for chemotherapy for stage IIIb-IV or postoperative recurrent squamous cell lung cancer patients. According to the test center, gender, disease staging (stage IIIB, IV/recurrence) and pathologic types, patients with squamous cell lung cancer were stratified and then randomly assigned to one of two groups. In the first group, 75 mg of docetaxel per square meter of body-surface area, administered on day 1, followed by 5\~6 mg boanmycin of per square meter and 5mg dexamethasone on days 3,5,10 and 12, the cycle was repeated every 21days. The second group received the reference treatment: docetaxel at a dose of 75 mg per square meter was administered on on day 1 of a three-week cycle. The efficacy was evaluated using RESIST standard after every 2 cycles of the treatment, the regimen will continue until the disease progression or the appearance of not tolerable toxicity.

Conditions

• Squamous Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Boanmycin	Boanmycin 5-6 mg/m2 + DXM 5mg IVD or IM, day 3,5,10,12, 21days a cycle.
DRUG	Docetaxel	Docetaxel 75mg/m2, intravenous infusion, day 1.

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2012-08-08
• Last updated: 2015-12-22

Locations

1 site across 1 country: China