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

December 21, 2015 updated by: Tianjin Medical University Cancer Institute and Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital
        • Principal Investigator:
          • Peng Chen, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 1.5 years
An Adverse Events is any unfavorable and unintended medical occurrence/sign (including an abnormal laboratory finding), symptom or disease in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
1.5 years
serious adverse event
Time Frame: 1.5 years
SAE is medically significant or requires intervention to prevent one or other of the outcomes, such as: Fatal (results in death);Life-Threatening Hospitalization; prolong hospitalization; Anomaly/birth defect or Disability/incapacity.
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Principal Investigator: Peng Chen, M.D., Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 5, 2012

First Submitted That Met QC Criteria

August 5, 2012

First Posted (Estimate)

August 8, 2012

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 21, 2015

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIH-CHP-201205001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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