Central Review-based Progression-Free Survival
| Group | Value (months) |
|---|---|
| Octreotide, Bevacizumab | 16.6 |
| Octreotide, Interferon Alpha-2b | 15.4 |
Trial · Interventional
Active, not recruitingPhase 3Results postedRegistry dataUnited States
1 trial · 1 ongoing · 1 with posted results
Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor
NCT005691271 Dec 2007 to est. 31 Jan 2027
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This randomized phase III trial studies octreotide acetate and recombinant interferon alfa-2b to see how well it works compared to octreotide acetate and bevacizumab in treating patients with high-risk neuroendocrine tumors that have spread to other places in the body (metastatic) or spread from where it started to nearby tissue or lymph nodes (locally advanced). Octreotide acetate and recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving octreotide acetate together with recombinant interferon alfa-2b is more effective than giving octreotide acetate together with bevacizumab in treating patients with neuroendocrine tumor.
Experimental
Arm I (octreotide acetate and bevacizumab)
Patients receive depot octreotide acetate IM and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Experimental
Arm II (octreotide acetate and recombinant interferon alfa-2b)
Patients receive octreotide acetate IM as in arm I on day 1 and recombinant interferon alfa-2b SC on days 1, 3, 5, 8, 10, 12, 15, 17, and 19. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Outcomes the sponsor listed as primary.
Central Review-based Progression-Free Survival
Time frame · Up to 3 years
From date of randomization (which is the date of registration) to date of first documentation of progression based on Central Radiological Review of the appropriate CT or MRI scans, or symptomatic deterioration (as defined in Section 10.2e)), or development of new lesions or disease not identified on CT or MRI, or death due to any cause. Patients who have a local assessment of progression based on imaging, but for whom central review does not concur, will be censored at the last Central Radiological Review date, unless subsequent scans or documentation of symptomatic deterioration provides evidence of progression. Patients last known not to have progressed are censored at the date of last contact. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not progressed prior to that time.
Overall Survival
Time frame · Up to 7 years
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time to Treatment Failure
Time frame · Up to 3 years
From date of randomization (which is the date of registration) to date of first observation of progressive disease (as defined in Section 10.2d), death due to any cause, symptomatic deterioration (as defined in Section 10.2e), or discontinuation of treatment. This has been calculated using Central-Review based progression events. Patients last known not to have failed treatment are censored at date last known not to have failed. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not failed treatment prior to that time.
Local Progression-Free Survival (Investigator Assessed)
Time frame · Up to 3 years
From date of randomization (which is the date of registration) to date of first documentation of progression \[per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as defined in Section 10.2d\] or symptomatic deterioration (as defined in Section 10.2e), or death due to any cause. Patients last known not to have progressed are censored at date of last contact. Progression (Section 10.2d) includes one or more of the following: 20% increase in the sum of the longest diameters of target measurable lesions over smallest sum observed using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of new lesion/site; or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration (Section 10.2e) is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response)
Time frame · Up to 3 years
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0): Complete Response (CR) is disappearance of all measurable and non-measurable disease, and no new lesions; Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Time frame · Up to 3 years
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (months) |
|---|---|
| Octreotide, Bevacizumab | 16.6 |
| Octreotide, Interferon Alpha-2b | 15.4 |
| Group | Value (months) |
|---|---|
| Octreotide, Bevacizumab | 35.2 |
| Octreotide, Interferon Alpha-2b | 47.3 |
| Group | Value (months) |
|---|---|
| Octreotide, Bevacizumab | 9.9 |
| Octreotide, Interferon Alpha-2b | 5.6 |
| Group | Value (months) |
|---|---|
| Octreotide, Bevacizumab | 15.4 |
| Octreotide, Interferon Alpha-2b | 10.6 |
| Group | Value (participants) |
|---|---|
| Octreotide, Bevacizumab | 2 |
| Octreotide, Interferon Alpha-2b | 0 |
| Group | Value (Participants) |
|---|---|
| Octreotide, Bevacizumab | 0 |
| Octreotide, Interferon Alpha-2b | 4 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Octreotide, BevacizumabPatients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. | – | 68 / 197 | 103 / 197 |
| Octreotide, Interferon Alpha-2bPatients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. | – | 9 / 194 | 98 / 194 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2017
Yao et al. 2017Journal of clinical oncology : official journal of the American Society of Clinical Oncologycited by 124
PMID 28384065PMC5455764DOI 10.1200/jco.2016.70.4072PUB-28384065
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