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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Bleomycin; Docetaxel

Criteria

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.