Study to Compare Capecitabine Combined With Dacarbazine(CAPDTIC) Versus Capecitabine Combined Temozolomide(CAPTEM) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Tumor

NCT ID: NCT03279601

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2020-09-01

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.

Conditions

Neuroendocrine Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Capecitabine, Dacarbazine

Intervention Type: DRUG

Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W Dacarbazine: 200mg/m2 ，iv drip,d1-5 q4W

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

Group Type: EXPERIMENTAL

Capecitabine, Temozolomide

Intervention Type: DRUG

Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ，p.o. bid d10-14 q4W,

Interventions

Capecitabine, Dacarbazine

Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W Dacarbazine: 200mg/m2 ，iv drip,d1-5 q4W

Intervention Type: DRUG

Capecitabine, Temozolomide

Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ，p.o. bid d10-14 q4W,

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. sign written informed consent form

2. age ≥ 18 years

3. pathologically confirmed well-differentiated neuroendocrine tumor;

4. 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;

5. 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);

6. 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;

7. KPS ≥ 70;

8. Predicted survival >=3 months;

9. Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women;

10. Sexually active males or females willing to practice contraception during the study until 30 days after end of study.

Exclusion Criteria

1. Hypersensitivity to capecitabine, dacarbazine or temozolomide;

2. 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;

3. Received surgery within past 4 weeks, or have not recovered from surgery;

4. Severe diarrhea;

5. Concurrent severe infection；

6. 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);

7. Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment)；

8. Meningeal carcinomatosis;

9. Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease；

10. 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；

11. Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;

12. 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 or successfully treated in situ carcinoma, are eligible；

13. Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons；

14. Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Shen Lin

MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lin Shen

Role: CONTACT

linshenpku@163.com

86-10-88196561

Facility Contacts

Shen Lin, Professor

Role: primary

Linshenpku@163.com

010-88196561

Other Identifiers

CAPDTIC vs. CAPTEM

Identifier Type: -

Identifier Source: org_study_id