Combination of Cisplatin, Docetaxel and Bevacizumab in Patients With Non-small Cell Lung Carcinoma (NSCLC)
This study is ongoing, but not recruiting participants.
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators:
Sanofi
Roche Pharma AG
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01368848
First received: June 7, 2011
Last updated: October 4, 2012
Last verified: October 2012
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Purpose
Despite recent advances in the treatment of NSCLC overall survival within these patients remains dismal and there is yet an unmet medical need for additional treatment options. In this phase II study a combination of chemotherapy with an antibody (cisplatin, docetaxel and bevacizumab) is tested to determine the objective response rate in patients with unresectable and advanced non-small cell lung cancer. This response rate will be compared with historical data.
| Condition | Intervention | Phase |
|---|---|---|
|
NSCLC |
Drug: Bevacizumab Drug: Cisplatin Drug: Docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study to Investigate the Treatment of Patients With NSCLC Stage IIIB and IV Without the Option of Surgery With a Combination of Cisplatin, Docetaxel and Bevacizumab |
Resource links provided by NLM:
Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
Primary Outcome Measures:
- Response Rate [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]The primary objective of this proof-of-concept study is to determine the objective response rate in patients with unresectable, stage IIIB and IV non-small cell lung carcinoma treated with the combination cisplatin, docetaxel and bevacizumab. This response rate will be compared to historical data from the ECOG4599 and AVAiL trials.
Secondary Outcome Measures:
- Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Progression free survival, defined as the duration of time from first study treatment until progression or death from any cause as documented by the investigator.
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Overall survival, defined as the duration of time from first study treatment until death from any cause.
- Duration of response [ Time Frame: 5 years ] [ Designated as safety issue: No ]Duration of response defined as timeframe from first response (CR or PR) until progression from best response.
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Bevacizumab
3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging
-> further 3 cycles BCD Q3W -> Bevacizumab Q3W until progression
Other Name: Avastin
Drug: Cisplatin
3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging
-> further 3 cycles BCD Q3W
3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging
-> further 3 cycles BCD Q3W
Other Name: Taxotere
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically documented inoperable, locally advanced, metastatic or recurrent NSCLC other than squamous cell
- At least 1 measurable lesion according to RECIST criteria
- ECOG performance score 0 or 1
- Age between 18 and 70 years
Exclusion Criteria:
- Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component.
- History of haemoptysis
- Evidence of tumour invading major blood vessels on imaging.
- Previous neoadjuvant/adjuvant chemotherapy.
- Previous radiotherapy.
- Serious uncontrolled coagulation disorder or thrombo-embolic complications within 6 months prior to study start or history of serious bleeding complications.
- Major surgical procedures within 4 weeks prior to study entry.
- Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
- Non-healing wound, active peptic ulcer or bone fracture.
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368848
Locations
| Austria | |
| Univ.-Klinik für Innere Medizin V Innsbruck, Abteilung für Hämatologie und Onkologie | |
| Innsbruck, Tirol, Austria, 6020 | |
| Landeskrankenhaus Feldkirch | |
| Feldkirch, Vorarlberg, Austria, 6806 | |
| Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III | |
| Salzburg, Austria, 5020 | |
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Sanofi
Roche Pharma AG
More Information
No publications provided
| Responsible Party: | Richard Greil, AGMT gemeinnützige GmbH |
| ClinicalTrials.gov Identifier: | NCT01368848 History of Changes |
| Other Study ID Numbers: | AGMT_NSCLC 1, 2008-000765-33 |
| Study First Received: | June 7, 2011 |
| Last Updated: | October 4, 2012 |
| Health Authority: | Austria: Federal Office for Safety in Health Care |
Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
|
AGMT NSCLC non-small cell lung cancer bevacizumab Avastin Cisplatin |
Docetaxel Taxotere Bevacizumab Inoperable stages IIIB and IV |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Docetaxel |
Bevacizumab Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013