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

NCT03279601 | Unknown Phase 2 DMC

• 1 other identifier: CAPDTIC vs. CAPTEM
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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

Keywords

chemotherapy; OS; ORR; PFS; safety

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1

  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

Secondary Outcomes (3)

• 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

Study Arms (2)

A: Capecitabine Combined With Dacarbazine(CAPDTIC)

EXPERIMENTAL

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

Drug: Capecitabine, Dacarbazine

B: Capecitabine Combined Temozolomide(CAPTEM)

EXPERIMENTAL

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

Drug: Capecitabine, Temozolomide

Interventions

Capecitabine, Dacarbazine DRUG

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

A: Capecitabine Combined With Dacarbazine(CAPDTIC)

Capecitabine, Temozolomide DRUG

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

B: Capecitabine Combined Temozolomide(CAPTEM)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• KPS ≥ 70;
• 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.

You may not qualify if:

• 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；
• Pregnant or nursing, or sexually active males or females refuse to practice contraception 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 or successfully treated in situ carcinoma, are eligible；
• Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons；
• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Capecitabine; Dacarbazine; Temozolomide

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Triazenes; Organic Chemicals; Imidazoles; Azoles

Central Study Contacts

Lin Shen

CONTACT

86-10-88196561; linshenpku@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital

Study Record Dates

• First Submitted: September 10, 2017
• First Posted: September 12, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2020
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)