A Study of Cixutumumab (IMC-A12) in Islet Cell Cancer (NCT00781911) | Clinical Trial Compass
CompletedPhase 2
A Study of Cixutumumab (IMC-A12) in Islet Cell Cancer
United States43 participantsStarted 2009-02
Plain-language summary
Determine the 6-month progression free survival (PFS) rate associated with cixutumumab in combination with depot octreotide acetate (octreotide) in participants with metastatic neuroendocrine tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* The participant has well-differentiated or moderately-differentiated, histologically confirmed neuroendocrine carcinoma, including carcinoid of any location and islet cell tumors
* The participant has metastatic disease at the time of study entry
* The participant must have a tumor measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, measurable by elevated tumor markers (eg, 24-hour urine 5-HIAA, chromogranin A, adrenocorticotropin hormone (ACTH), gastrin, or other tumor specific biochemical markers), or both
* The participant is age ā„ 18 years
* The participant's tumor has Ki-67 expression ⤠20%
* The participant is receiving depot octreotide therapy at the time of enrolling into the study
* The participant has received 0 - 2 systemic anticancer regimens in addition to depot octreotide, which may have included chemotherapy, interferon, antiangiogenic therapy, other targeted treatments, or a combination of such treatments
* The participant is no longer a candidate for surgery, embolization, or radiofrequency ablation therapy
* The participant has experienced radiographic, biochemical, and/or scintigraphic disease progression while on a regimen that includes octreotide
* The participant has completed prior chemotherapy and/or radiotherapy with curative intent at least 3 weeks prior to the administration of the first dose of study therapy. Participants that have received palliative radiation therapy to bony metastases ā¦
What they're measuring
1
Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months
Timeframe: From Start of Study Treatment to Progressive Disease or Death Due to Any Cause (Up to 6 Months)