A Randomized, Controlled Phase II Study to Compare Capecitabine Combined With Dacarbazine(CAPDTIC) Versus Capecitabine Combined Temozolomide(CAPTEM) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Tumor
Overview
- Phase
- Phase 2
- Intervention
- Capecitabine, Dacarbazine
- Conditions
- Neuroendocrine Tumors
- Sponsor
- Peking University
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- Overall response rate (ORR)
- Last Updated
- 8 years ago
Overview
Brief Summary
The study will be conducted to compare the safety and efficacy of Capecitabine Combined With Dacarbazine(CAPDTIC) and Capecitabine Combined Temozolomide(CAPTEM) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine tumor.In this prospective randomized phase II study, the investigators aim to compare the survival benefit as well as the safety forCapecitabine Combined With Dacarbazine(CAPDTIC) versus Capecitabine Combined Temozolomide(CAPTEM) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine tumor.
Investigators
Shen Lin
MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital
Peking University
Eligibility Criteria
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. For recurrent patients after radical surgery, adjuvant chemotherapy should not include capecitabine, dacarbazine or temozolomide, and the last date should beyond 6 months prior 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 measurable lesions);
- •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; total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1╳ULN;
- •Predicted survival \>=3 months;
- •Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women;
- •Sexually active males or females willing to practice contraception during the study until 30 days after end of study.
Exclusion Criteria
- •Hypersensitivity to capecitabine, dacarbazine or temozolomide;
- •Prior antitumor therapy (including corticosteroids and immunotherapy) or participation in other clinical trials within past 4 weeks, or have not recovered from toxicities since 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 or obscure the interpretation of toxicity determination or adverse events, including severe liver disease (active hepatitis, cirrhosis), uncontrolled diabetes or hypertension, or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm);
- •Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to \> 2 weeks of study enrollment)；
- •Meningeal carcinomatosis;
- •Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease；
- •Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency；
Arms & Interventions
A: Capecitabine Combined With Dacarbazine(CAPDTIC)
patients in arm A will receive chemotherapy of CAPDTIC regimen: Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Dacarbazine: 200mg/m2 ，iv drip,d1-5 q4W
Intervention: Capecitabine, Dacarbazine
B: Capecitabine Combined Temozolomide(CAPTEM)
patients in arm B will receive chemotherapy of CAPDTEM regimen: Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ，p.o.d10-14 q4W
Intervention: Capecitabine, Temozolomide
Outcomes
Primary Outcomes
Overall response rate (ORR)
Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1
Secondary Outcomes
- Progression-free survival(baseline, every 8 weeks up to 1 year after last patient first treatment)
- Overall survival(baseline, every 8 weeks up to 1 year after last patient first treatment)
- Incidence of Treatment-Emergent Adverse Events （Safety and Tolerability）(From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)