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

NCT01660399 | Unknown Phase 2 DMC

• 1 other identifier: CIH-CHP-201205001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Squamous Cell Lung Cancer

Keywords

salvage chemotherapy; advanced squamous cell lung cancer; Boanmycin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• overall survival

  1.5 years

Other Outcomes (2)

• Adverse Events

  1.5 years

• serious adverse event

  1.5 years

Study Arms (2)

Docetaxel/Boanmycin

EXPERIMENTAL

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; Drug: Docetaxel

Docetaxel

PLACEBO COMPARATOR

Docetaxel 75mg/m2, intravenous infusion, day 1, 21days a cycle.

Drug: Docetaxel

Interventions

Boanmycin DRUG

Boanmycin 5-6 mg/m2 + DXM 5mg IVD or IM, day 3,5,10,12, 21days a cycle.

Also known as: Boanmycin Hydrochloride for Injection

Docetaxel/Boanmycin

Docetaxel DRUG

Docetaxel 75mg/m2, intravenous infusion, day 1.

Also known as: Docetaxel for Injection

Docetaxel; Docetaxel/Boanmycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (11)

• Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ. 1995 Oct 7;311(7010):899-909.

  PMID: 7580546 RESULT

• Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.

  PMID: 11784875 RESULT

• Socinski MA, Schell MJ, Peterman A, Bakri K, Yates S, Gitten R, Unger P, Lee J, Lee JH, Tynan M, Moore M, Kies MS. Phase III trial comparing a defined duration of therapy versus continuous therapy followed by second-line therapy in advanced-stage IIIB/IV non-small-cell lung cancer. J Clin Oncol. 2002 Mar 1;20(5):1335-43. doi: 10.1200/JCO.2002.20.5.1335.

  PMID: 11870177 RESULT

• Buter J, Giaccone G. EGFR inhibitors in lung cancer. Oncology (Williston Park). 2005 Nov;19(13):1707-11; discussion 1711-2, 1720-3.

  PMID: 16425523 RESULT

• Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.

  PMID: 17167137 RESULT

• Eberhard DA, Johnson BE, Amler LC, Goddard AD, Heldens SL, Herbst RS, Ince WL, Janne PA, Januario T, Johnson DH, Klein P, Miller VA, Ostland MA, Ramies DA, Sebisanovic D, Stinson JA, Zhang YR, Seshagiri S, Hillan KJ. Mutations in the epidermal growth factor receptor and in KRAS are predictive and prognostic indicators in patients with non-small-cell lung cancer treated with chemotherapy alone and in combination with erlotinib. J Clin Oncol. 2005 Sep 1;23(25):5900-9. doi: 10.1200/JCO.2005.02.857. Epub 2005 Jul 25.

  PMID: 16043828 RESULT

• Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U; FLEX Study Team. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31. doi: 10.1016/S0140-6736(09)60569-9.

  PMID: 19410716 RESULT

• Fossella FV, Lee JS, Shin DM, Calayag M, Huber M, Perez-Soler R, Murphy WK, Lippman S, Benner S, Glisson B, et al. Phase II study of docetaxel for advanced or metastatic platinum-refractory non-small-cell lung cancer. J Clin Oncol. 1995 Mar;13(3):645-51. doi: 10.1200/JCO.1995.13.3.645.

  PMID: 7884425 RESULT

• Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y, Berille J. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol. 2000 May;18(10):2095-103. doi: 10.1200/JCO.2000.18.10.2095.

  PMID: 10811675 RESULT

• MA Jinlan, FENG Fengyi, ZHOU Liqiang, SUN Yan.Pharmacokinetics Study and Clinical Evaluation on Boanmycin.China Pharmacy 16(17):1314-1315, 2005.

  RESULT

• Wang Ping hui, Liu Liping, Hou Yuanshu et al.Phase II Clinical Trial of The New Anticancer Drug-Boanmycin.Chinese Journal of Clinical Oncology 25(9):657-659, 1998.

  RESULT

MeSH Terms

Interventions

bleomycin A6; Injections; Docetaxel

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Peng Chen, M.D.

  Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Chen, M.D.

CONTACT

+86-13702152241; chenpengdoc@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2012
• First Posted: August 8, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 22, 2015

Record last verified: 2012-08

Locations

CN (1)