Capecitabine, Temozolomide, and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocr… (NCT01525082) | Clinical Trial Compass
CompletedPhase 2
Capecitabine, Temozolomide, and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors
United States20 participantsStarted 2012-12
Plain-language summary
The purpose of this research is to evaluate the effectiveness and safety of a combination of capecitabine, temozolomide and bevacizumab in the treatment of advanced pancreatic neuroendocrine tumors.
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
* Histologically-confirmed pancreatic neuroendocrine tumors that are moderately- or well-differentiated
* Metastatic or unresectable disease
* If prior surgical resection \> 5 years before the development of metastatic disease, a separate (recent) histological or cytological confirmation of metastatic disease is required
* If there is substantial clinical ambiguity regarding the nature or source of apparent metastases, clinicians should consider biopsy of lesions to establish diagnosis of metastatic disease
* The site of previous radiotherapy, if the only site of disease, has evidence of progressive disease
* If prior sunitinib and everolimus has been administered, a 2-week wash-out period is required prior to 1st dose on this study
* If prior liver-directed therapies (ie, chemoembolization, radioembolization), target lesions in the liver have demonstrated growth since the liver-directed treatment
* If prior peptide receptor radionuclide therapy (PRRT), target lesions in the liver have demonstrated growth since the liver-directed treatment
* Low-dose aspirin (≤ 325 mg/d) may be continued in subjects at higher risk for arterial thromboembolic disease.
* Primary or metastatic tumor lesion measurable in at least 1 dimension, within 4 weeks prior to entry of study.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* ≥ 18 years of age.
* Laboratory values as follows, ≤ 2 weeks prior to randomization:
* Absolute neutrophil count (ANC) ≥ 1.…