Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma (NCT00093782) | Clinical Trial Compass
CompletedPhase 2
Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma
Canada36 participantsStarted 2003-12
Plain-language summary
This phase II trial is studying how well CCI-779 works in treating patients with progressive metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed neuroendocrine tumours either of carcinoid histology or a carcinoma of pancreatic islet cell origin; small cell variant, endocrine organ carcinomas, and adrenal gland malignancies (including paragangliomas) are excluded from this study
* Patients must have progressive metastatic disease defined by one of the following occurring within 6 months of study entry:
* At least a 25% increase in radiologically or clinically measurable disease
* Appearance of any new lesion or
* Deterioration in clinical status
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan
* Previous local therapy (e.g. chemoembolization or bland embolization) allowed if completed \> 6 weeks prior to study entry; for patients who received local therapy prior to study entry, there must be either progression of measurable disease documented within the treatment field, or must have measurable disease outside the treatment field prior to study entry
* Previous chemotherapy, investigational agents or radioactive therapies (e.g. radioactive octreotide) allowed if completed \> 4 weeks prior to study entry (\> 6 weeks if last regimen contained BCNU or mitomycin C); for patients who received systemic therapy prior to study entry, there must be d…
What they're measuring
1
Objective Tumor Response Rate (Defined as Partial or Complete Response as Defined by the RECIST Criteria)