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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Squamous Cell Lung Cancer

Intervention / Treatment
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* Drug: Boanmycin
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically or cytology confirmed III，IV or after operation recurrent squamous cell lung cancer; disease progressed after first-line chemotherapy and not suitable for EGFR-TKI; no radiotherapy for metastases outside the lung 4 weeks before; the lesions are measurable in CT images and are measured follow criteria RECIST 1.1 2 weeks before randomization; ECOG scale 0-1, expected survival>3 month; white blood count ≥ 3,500/mm3, absolute neutrophil≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin count≥ 90 g/dL；serum bilirubin level ≤ 1.5 of the upper limit of normal(ULN) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase≤ 2.5 ULN, serum creatinine≤ 1.5 ULN; with good compliance； Exclusion Criteria: past history of major operation in 4 weeks; involved in other clinical trials in 4 weeks; past history of central nervous system or relevant disease except for well-controlled CNS metastasis; past history of other cancers except for cured non-melanoma skin cancer or cervical cancer; concomitant treatment with other anticancer drugs. pregnancy, breast feeding or fertility but not taking contraceptive device during the trials; radiotherapy for target lesions in lung; clear TKI-related mutation in EGFR; with severe heart disease, hypertension, diabetes mellitus or active infection. past history of allergy to taxanes; past history of severe acute or chronic kidney disease; active hepatitis b or HIV positive patients; cannot tolerate Corticosteroid; past history of COPD or other critical basic pulmonary diseases; history of severe mental illness.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel/Boanmycin<br>Docetaxel 75mg/m2, intravenous infusion, day 1; Boanmycin 5-6 mg/m2 + DXM 5mg IVD or IM, day 3,5,10,12, 21days a cycle. | Drug: Boanmycin<br>* Boanmycin 5-6 mg/m2 + DXM 5mg IVD or IM, day 3,5,10,12, 21days a cycle.<br>* Other names: Boanmycin Hydrochloride for Injection;Drug: Docetaxel<br>* Docetaxel 75mg/m2, intravenous infusion, day 1.<br>* Other names: Docetaxel for Injection;|
| Placebo Comparator: Docetaxel<br>Docetaxel 75mg/m2, intravenous infusion, day 1, 21days a cycle. | Drug: Docetaxel<br>* Docetaxel 75mg/m2, intravenous infusion, day 1.<br>* Other names: Docetaxel for Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | DFS was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death. | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | OS was defined as the length of time from the date of randomization to the date of death of various reasons. | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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salvage chemotherapy, advanced squamous cell lung cancer, Boanmycin