A Multicenter, Open-label, Phase 2 Study of VELCADE (bortezomib) for Injection in Previously Treated Patients with Stage IIIB and IV Bronchioloalveolar Carcinoma and Adenocarcinoma with Bronchioloalveolar Features - VANTAGE
- Conditions
- Stage IIIB and IV Bronchioloalveolar Carcinoma and Adenocarcinoma with Bronchioloalveolar Features
- Registration Number
- EUCTR2004-004648-29-DE
- Lead Sponsor
- Janssen Cilag International, N.V. (Sponsor in European Union)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 135
1. Have histologically confirmed BAC or adenocarcinoma with BAC features.
2. Have stage IIIB (malignant pleural effusion) or stage IV disease.
3. Have disease that has progressed on or after treatment with an EGFR TKI
(Iressa or Tarceva).
4. Have radiographic documentation of Progressive Disease (PD) as determined by
the investigator.
5. Have measurable disease by RECIST, defined as at least 1 lesion that can be
accurately measured in at least 1 dimension as >20 mm with conventional tech-
niques or >10 mm with spiral CT scan; the longest diameter is to be recorded.
6. Are 18 years of age or older.
7. Have a life expectancy greater than 3 months.
8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of
0, 1, or 2.
9. Are able to provide written informed consent in accordance with all applicable
regulations and follow the study procedures. Patients must be capable of un-
derstanding the investigational nature, potential risks and benefits of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Have a histological diagnosis of BAC or adenocarcinoma with BAC features based
solely on the following sample types:
·fine needle aspirate (FNA)
·sputum cytology
·bronchial brushings and washings cytology (bronchioalveolar lavage)
·bronchial biopsy (bronchial wall only with no alveolar parenchyma, or
mediastinoscopy with lymph node metastasis only).
2. Have had conventional cytotoxic chemotherapy within 3 weeks prior to en-
rollment or treatment with an EGFR TKI within 2 weeks prior to enrollment.
3. Have peripheral neuropathy of Grade 2 or greater intensity, as defined by the
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
(CTCAE 3.0).
4. Have documented greater than 10% weight loss in the 6 weeks prior to
enrollment.
5. Have been previously treated with VELCADE.
6. Have experienced myocardial infarction within 6 months prior to enrollment or
have New York Hospital Association (NYHA) Class III or IV heart failure, un-
controlled angina, electrocardiographic evidence of acute ischemia, or clinically
significant and poorly controlled arrhythmias.
7. Have had radiation therapy within 4 weeks prior to enrollment.
8. Have had monoclonal antibody therapy within 4 weeks prior to enrollment.
9. Have had any major surgery within 4 weeks prior to enrollment
10. Have inadequate organ function at the Screening Visit as defined by the
following laboratory values:
- Platelet count <100 x 109/l
- Hemoglobin <8.0 g/dl
- Absolute neutrophil count (ANC) <1.5 x109/l
- Aspartate transaminase (AST) >3 times the upper limit of the normal range
(ULN)
- Alanine transaminase (ALT) >3 times ULN
- Creatinine >1.8 mg/dl
- Total bilirubin >1.5 times ULN or >=5 times ULN in patients with liver
metastases
11. Have brain metastases that have not been completely resected or have not
completely responded to treatment with radiation therapy and there is evidence
of residual disease; or that require ongoing treatment with corticosteroids.
12. Have uncontrolled active systemic infection requiring treatment
13. Have evidence of a co-existing advanced or metastatic malignancy other than
BAC or adenocarcinoma with BAC features.
14. Have a history of allergic reaction attributable to compounds containing boron or
mannitol.
15. Have known human immunodeficiency virus (HIV) positive or hepatitis B surface
antigen-positive status or known active hepatitis C infection. Patients assessed
by the investigator to be at risk for HIV, hepatitis B or C infection should be
tested in accordance with local regulations.
16. Have poorly controlled hypertension, diabetes mellitus, or another serious
medical or psychiatric illness that could, in the investigator's opinion, potentially
interfere with the completion of treatment according to this protocol.
17. Are a pregnant or breast-feeding female. Confirmation that the patient is not
pregnant must be established by a negative serum or urine beta-human
chorionic gonadotropin (beta-hCG) pregnancy test result obtained during the
Screening Period. Pregnancy testing is not required for post-menopausal or
surgically sterilized women.
18. Are of childbearing potential and are unwilling to employ adequate means of
contraception (condoms, diaphragm, birth control pi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method