A multicenter, open-label, single-arm, two-stage study of the efficacy and safety of AVE0005 (VEGF Trap) administered intravenously every 2 weeks in patients with platinum- and erlotinib-resistant, locally advanced or metastatic non-small-cell lung adenocarcinoma.
- Conditions
- patients with platinum- and erlotinib-resistant, locally advanced or metastatic non-small-cell lung adenocarcinoma.
- Registration Number
- EUCTR2006-006144-55-FR
- Lead Sponsor
- sanofi-aventis recherche & développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 94
1. Histologically-confirmed non-small-cell lung adenocarcinoma that is locally advanced or metastatic.
2. Prior treatment with at least 2 cancer drug regimens in the advanced disease treatment setting.
3. Platinum- and erlotinib-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.
4. Evidence of at least one unidimensionally measurable tumor lesion by CT or MRI scan according to RECIST criteria that has not been treated with surgery or radiation therapy.
5. Eighteen years of age or older.
6. ECOG performance status =2.
7. Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE v.3.0 grade =1 and to baseline laboratory values as defined in inclusion criterion #8.
8. Adequate organ and bone marrow function as evidenced by:
a. hemoglobin =9.0 g/dL
b. absolute neutrophil count =1.5 x 10 9 /L
c. platelet count =75 x 10 9 /L
d. creatinine =1.5 x ULN, and either proteinuria =500 mg/24 hours or urine protein:creatinine ratio (UPCR) =1
e. AST/SGOT and ALT/SGPT =2.5 x ULN
f. total bilirubin =1.5 x ULN
9. Female patients must be postmenopausal, surgically sterile, or using effective contraception.
All female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment.
10. Patients must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Informed consent must be obtained in writing for all patients prior to enrollment into 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. Diagnosis of squamous-cell lung cancer, or any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
2. Prior treatment with a VEGF or VEGF receptor inhibitor with the exception of bevacizumab (Avastin™).
3. Anticipation of a need for a major surgical procedure (e.g., impending bowel obstruction) or radiation therapy during the study.
4. Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 8.9).
5. History of hypersensitivity to any Trap agents.
6. Treatment with chemotherapy, radiotherapy, surgery, blood products, or an investigational agent within 3 weeks (6 weeks for nitrosoureas, mitomycin C, immunotherapy, or cytokine therapy) of study enrollment.
7. Uncontrolled hypertension, defined as blood pressure >150/100 mm Hg (NCI CTCAE v.3.0 grade =2), or systolic blood pressure >180 mm Hg if diastolic blood pressure <90 mm Hg, on at least 2 repeated determinations on separate days within 3 months prior to study enrollment.
8. Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure (see Appendix A), cerebrovascular accident or transient ischemic attack, grade =2 peripheral neuropathy, peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
9. History of brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening CT or MRI scan.
10. Evidence of clinically significant bleeding diathesis including hemoptysis, or underlying coagulopathy.
11. Active infection, or on antiretroviral therapy for HIV disease.
12. Patient is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
13. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
14. Patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
15. Refusal or inability to give informed consent to participate in the study.
16. Pregnancy or breastfeeding.
17. Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient’s safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
A patient may not be enrolled in this study more than once.
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