Phase
Condition
Carcinoid Syndrome And Carcinoid Tumours
Digestive System Neoplasms
Abdominal Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
sign written informed consent form
age ≥ 18 years
pathologically confirmed well-differentiated neuroendocrine tumor;
No prior antitumor treatment of capecitabine, dacarbazine or temozolomide. Forrecurrent patients after radical surgery, adjuvant chemotherapy should not includecapecitabine, dacarbazine or temozolomide, and the last date should beyond 6 monthsprior to randomization;
At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurablelesions);
Screening laboratory values must meet the following criteria (within past 7 days):hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10^3/ μL; totalbilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alaninetransaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serumcreatinine ≤1╳ULN;
KPS ≥ 70;
Predicted survival >=3 months;
Negative serum or urine pregnant test within 7 days prior to randomization forchild-bearing age women;
Sexually active males or females willing to practice contraception during the studyuntil 30 days after end of study.
Exclusion
Exclusion Criteria:
Hypersensitivity to capecitabine, dacarbazine or temozolomide;
Prior antitumor therapy (including corticosteroids and immunotherapy) or participationin other clinical trials within past 4 weeks, or have not recovered from toxicitiessince the last treatment;
Received surgery within past 4 weeks, or have not recovered from surgery;
Severe diarrhea;
Concurrent severe infection;
Severe, uncontrolled medical condition that would affect patients' compliance orobscure the interpretation of toxicity determination or adverse events, includingsevere liver disease (active hepatitis, cirrhosis), uncontrolled diabetes orhypertension, or pulmonary disease ( interstitial pneumonia, obstructive pulmonarydisease or symptomatic bronchospasm);
Prior long term steroid therapy (excluding short term steroid treatment which iscompleted prior to > 2 weeks of study enrollment);
Meningeal carcinomatosis;
Patients with central nervous system(CNS) disorder or peripheral nervous systemdisorder or psychiatric disease;
Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias andhypertension, or congestive heart failure, or cardiac infarction within 6 months priorto study enrollment, or cardiac insufficiency;
Pregnant or nursing, or sexually active males or females refuse to practicecontraception during the study until 30 days after end of study;
History of other malignancy. However, subjects who have been disease-free for 5 years,or subjects with a history of completely resected non-melanoma skin cancer orsuccessfully treated in situ carcinoma, are eligible;
Person with no capacity (legally) or inappropriate to continue study treatment forethics/medical reasons;
Underlying medical condition that, in the Investigator's opinion, would increase therisks of study drug administration or obscure the interpretation of toxicitydetermination or adverse events.
Study Design
Connect with a study center
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaActive - Recruiting
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