Objective Response Rate (ORR)
| Group | Value (percentage of participants) |
|---|---|
| Typical Carcinoid | 16 |
| Pancreatic Islet Cell | 18 |
| All Patients | 16 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers
NCT01121939May 2010 to Aug 2015
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this Phase II trial will be to define the activity of a VEGF inhibitor bevacizumab, HER1/HER2 inhibitor pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers. In particular, the efficacy of bevacizumab and pertuzumab treatment is of great interest. The primary endpoint of this trial will be response rate. Toxicity and progression-free survival will be obtained and evaluated.
Experimental
1
combination of bevacizumab, pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers
Outcomes the sponsor listed as primary.
Objective Response Rate (ORR)
Time frame · 18 months
The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Define Toxicity and Safety
Time frame · 18 months
To define the toxicity and safety of the combination of bevacizumab, pertuzumab and Sandostatin LAR® when used in patients with advanced low grade neuroendocrine cancer - defined by grade 3/4, treatment-related toxicity
Progression-Free Survival (PFS)
Time frame · 18 months
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Overall Survival (OS)
Time frame · 18 months
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Disease Control Rate
Time frame · 18 months
The Percentage of Patients Who Experience an Objective Benefit From Treatment or Experience Stable Disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither Sufficient Shrinkage to Qualify For PR, Nor Sufficient Increase to Qualify for Progressive Disease; Disease Control Rate = CR + PR + SD.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| Typical Carcinoid | 16 |
| Pancreatic Islet Cell | 18 |
| All Patients | 16 |
| Group | Value (participants) |
|---|---|
| All Patients | 11 |
| Group | Value (months) |
|---|---|
| Typical Carcinoid | 11.96 |
| Pancreatic Islet Cell | 5.49 |
| Group | Value (months) |
|---|---|
| Typical Carcinoid | NA |
| Pancreatic Islet Cell | 26.4 |
| Group | Value (percentage of participants) |
|---|---|
| Typical Carcinoid | 72 |
| Pancreatic Islet Cell | 91 |
| All Patients | 77 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| All PatientsBevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over 90 minutes. If no adverse reactions occur after the initial dose, the second dose should be administered over a minimum of 60 minutes. If no adverse reactions occur after the second dose, all subsequent doses should be administered over a minimum of 30 minutes. Bevacizumab will be infused prior to pertuzumab. Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes. Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection. | – | 6 / 43 | 42 / 43 |
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