Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus the Cisplatin/Docetaxel/Bevacizumab Combination in Locally Advanced or Metastatic NSCLC
This study has been withdrawn prior to enrollment.
(Due to poor accrual of the study)
Sponsor:
Hellenic Oncology Research Group
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00620971
First received: January 31, 2008
Last updated: April 8, 2010
Last verified: April 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This trial will evaluate whether the sequential administration of Cisplatin/Vinorelbine/Bevacizumab followed by Docetaxel/Gemcitabine/Bevacizumab versus the Cisplatin/Docetaxel/Bevacizumab combination as first line treatment offers a survival advantage in patients with locally advanced or metastatic NSCLC.
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Drug: Vinorelbine Drug: Cisplatin Drug: Bevacizumab Drug: Docetaxel Drug: Gemcitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sequential Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus Cisplatin/Docetaxel/Bevacizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer |
Resource links provided by NLM:
Drug Information available for:
Cisplatin
Vinorelbine
Gemcitabine
Docetaxel
Gemcitabine hydrochloride
Vinorelbine tartrate
Bevacizumab
U.S. FDA Resources
Further study details as provided by Hellenic Oncology Research Group:
Primary Outcome Measures:
- Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to Tumor Progression [ Time Frame: 1-year ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Quality of life assessment [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 350 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
NC/Avastin->DG/Avastin
|
Drug: Vinorelbine
Vinorelbine (oral) 60 mg/m2, on days 1 and 8 every 3 weeks for 3 cycles
Other Name: Navelbine
Drug: Cisplatin
Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles
Other Name: CDDP
Drug: Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles
Other Name: Avastin
Drug: Docetaxel
Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
Other Name: Taxotere
Drug: Gemcitabine
Gemcitabine(IV) 1,100 mg/m2 on day 1 and d8 every 3 weeks for 6 cycles
Other Name: Gemzar
Drug: Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
Other Name: Avastin
|
|
Experimental: 2
DG/Avastin
|
Drug: Docetaxel
Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
Other Name: Taxotere
Drug: Cisplatin
Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles
Other Name: CDDP
Drug: Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
Other Name: Avastin
|
Detailed Description:
An unanswered question in first line treatment of non small cell lung cancer (NSCLC) is whether the administration of more than 2 active drugs provides greater efficacy than a two-drug combination. Docetaxel/gemcitabine combination is a well tolerated regimen, which has comparable efficacy to docetaxel/cisplatin or vinorelbine/cisplatin. In a recent phase II study in first line treatment of advanced or metastatic NSCLC, the sequential administration of vinorelbine/cisplatin followed by docetaxel/gemcitabine produced a response rate of 45.8% and a 1-year survival rate of 51%. The addition of bevacizumab to a platinum-based regimen provided a survival benefit in patients with advanced or metastatic NSCLC.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) or metastatic (stage IV) non-squamous NSCLC
- Performance status (WHO) 0-1
- Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 2.5 UNL, ALP ≤ 5 UNL), and renal function (Creatinine ≤ UNL - if borderline, creatinine clearance should be ≥ 60 mL/min)
No previous chemotherapy or immunotherapy for advanced/metastatic NSCLC is allowed
--Previous radiotherapy is allowed provided that the measurable lesions are outside the radiation fields
- Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm
- Patient able to take oral medication
- Absence of active CNS disease
- Paraffin embedded sample of primary or metastatic tumor diagnostic specimen must be available
- Patients must be able to understand the nature of this study and give written informed consent
Exclusion Criteria:
- Pregnant or lactating women
- Women of child-bearing age unable or unwilling to take effective contraceptive measures
- Active CNS disease, brain metastases, or leptomeningeal involvement
- Symptomatic neuropathy > grade1 according to the NCI CTCAE (version 3.0)
- Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, LVEF < normal, uncontrolled hypertension, ventricular arrhythmia), anticoagulation treatment or thrombotic event within the previous 6 months
- Active infection, requiring IV antibiotic treatment, within the previous 2 weeks
- Long-term oxygen therapy
- Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
- Radiotherapy within the previous 4 weeks
- Previous radiotherapy to the only measurable lesion
- Concurrent treatment with other anti-cancer drug
- Uncontrolled hypercalcemia
- Known allergy to drugs with similar chemical structure to study drugs. Concurrent corticosteroids, except for chronic therapy with methylprednisolone ≤ 20 mgr daily (or equivalent) for more than one month
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620971
Locations
| Greece | |
| University General Hospital of Alexandroupolis, Dep of Medical Oncology | |
| Alexandroupolis, Greece | |
| Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases | |
| Athens, Greece | |
| Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases | |
| Athens, Greece | |
| "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | |
| Athens, Greece | |
| IASO" General Hospital of Athens, 1st Dep of Medical Oncology | |
| Athens, Greece | |
| 401 Military Hospital, Medical Oncology Unit | |
| Athens, Greece | |
| Air Forces Military Hospital, Dep of Medical Oncology | |
| Athens, Greece | |
| "Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology | |
| Athens, Greece | |
| "Theagenion" Anticancer Hospital of Thessaloniki | |
| Thessaloniki, Greece | |
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
| Principal Investigator: | Vassilis Georgoulias, MD | University Hospital of Crete, Dep of Medical Oncology |
More Information
No publications provided
| Responsible Party: | V.Georgoulias, Hellenic Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT00620971 History of Changes |
| Other Study ID Numbers: | CT/07.19 |
| Study First Received: | January 31, 2008 |
| Last Updated: | April 8, 2010 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by Hellenic Oncology Research Group:
|
Non Small Cell Lung Cancer Cisplatin VInorelbine |
Docetaxel Gemcitabine Bevacizumab |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Vinorelbine Docetaxel Bevacizumab Cisplatin |
Vinblastine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013