Ziv-Aflibercept for Advanced Progressive Carcinoid Tumors
Palavras-chave
Resumo
Descrição
If you are willing to participate in this study you will be asked to undergo some screening tests and procedures to confirm that you are eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include: a medical history, physical examination, CT or MRI, blood tests, serum chromogranin A, urine tests, 24-hour urine collection, pregnancy test and an electrocardiogram. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
If you meet the requirements for this study and you agree to continue your participation, you will receive Ziv-aflibercept every two weeks. Each dose of Ziv-aflibercept consists of an approximately 60 minutes infusion (through a needle into a vein). You will also receive an injection of Octreotide LAR (long acting release) monthly as part of your treatment for carcinoid tumor. This injection will be given to you by a nurse in your buttock. You may already be on Octreotide LAR. In that case, you will continue taking it at the same dose and schedule.
You will need to come to the clinic every two weeks while participating in this study. Each cycle is 28 days.
The following tests and procedures will be performed on Days 1 and 15 of each cycle: questions about your health, physical exam (Day 1 of each cycle only), vital signs, blood tests, pregnancy test (Day 1 of each cycle only).
Urine tests will be performed every other cycle.
The following tests and procedures will be done at the end of every third cycle: CT scan or MRI, Serum Chromogranin A, 24-hour urine collection.
After the final dose of the study drug the following tests and procedures will be performed: questions about your general health, physical exam, vital signs, blood tests, pregnancy test, EKG, Serum Chromogranin A, 24-hour urine collection.
datas
| Última verificação: | 03/31/2020 |
| Enviado pela primeira vez: | 01/30/2013 |
| Inscrição estimada enviada: | 01/30/2013 |
| Postado pela primeira vez: | 01/31/2013 |
| Última atualização enviada: | 04/23/2020 |
| Última atualização postada: | 04/26/2020 |
| Data real de início do estudo: | 02/12/2013 |
| Data Estimada de Conclusão Primária: | 05/31/2020 |
| Data Estimada de Conclusão do Estudo: | 11/30/2021 |
Condição ou doença
Intervenção / tratamento
Drug: Experimental Treatment Arm
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Experimental: Experimental Treatment Arm Ziv-aflibercept IV every 2 weeks, 4 mg/kg | Drug: Experimental Treatment Arm |
Critério de eleição
| Idades qualificadas para estudar | 18 Years Para 18 Years |
| Sexos elegíveis para estudo | All |
| Aceita Voluntários Saudáveis | sim |
| Critério | Inclusion Criteria: - Histologically confirmed well differentiated or moderately differentiated neuroendocrine tumor from either a primary or metastatic site - Must have disease that is not amenable to curative resection - Must have evidence of disease progression within 12 months prior to study entry - Must have measurable disease (RECIST 1.1) - Prior chemoembolization of local ablative therapies are allowed, provided there is measurable disease outside of the area treated, or documented evidence of progression at the site of prior treatment - No limit to number of prior treatments. Prior bevacizumab allowed unless discontinued due to unacceptable toxicity. Prior TKI targeting VEGF receptors allowed - Treatment with a somatostatin analog required for all subjects - Subjects with history of hypertension must be adequately controlled - Therapeutic anticoagulation is allowed. Must be on a stable dose of anticoagulant medication - Must agree to use adequate contraception prior to study entry, for the duration of study participation and for 3 months after last administration of study drug Exclusion Criteria: - Prior treatment including chemoembolization within 4 weeks of study entry - Major surgery within 4 weeks of study entry or minor surgery within 2 weeks of study entry - Pregnant or breastfeeding - Poorly differentiated carcinoma, high grade neuroendocrine tumor or small cell carcinoma - Prior treatment with Ziv-aflibercept - Pancreatic neuroendocrine tumor (islet cell carcinoma)will be excluded from this study. All non functional and functional islet cell carcinomas such as insulinoma, glucagonoma, gastrinoma, VIPoma will be excluded. - Not adequately recovered from toxicity of previous therapy - Known untreated brain or other central nervous system metastases - Known allergy to any of the study agents or to compounds of similar chemical or biologic composition - History of congestive heart failure - Symptomatic peripheral arterial disease - Unhealed wounds, ulcers or bone fractures - HIV positive or active Hepatitis infection - History of abdominal fistula, GI perforation, intra abdominal abscess, uncontrolled GI bleeding, diverticulitis within 6 months of study entry - History of arterial thrombotic events such as myocardial infarction, unstable angina pectoris or any ischemic or hemorrhagic cerebrovascular accident within the past 6 months - No history of pulmonary embolism, DVT or vascular access related thrombosis if not also receiving adequate anticoagulation at a stable dose. - No history of prior or synchronous malignancy except if treated with curative intent at least 3 years prior to study entry, or adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or prostate intraepithelial neoplasia without evidence of prostate cancer - Uncontrolled non-malignant illness that may increase the risks associated with study participation or may interfere with the conduct of the study or interpretation of study results - Uncontrolled psychiatric illness or social situations that would limit compliance with study requirements |
Resultado
Medidas de Resultado Primário
1. Progression Free Survival [2 years]
Medidas de Resultado Secundário
1. Safety and Tolerability of Ziv-aflibercept [2 years]
2. Evaluation of Disease Response [2 years]
3. Evaluation of Biochemical Response [2 years]
