Intraperitoneal and System Chemotherapy Versus XELOX as First-line Chemotherapy for mCRC

NCT03792269 | Unknown Phase 2

• 1 other identifier: mCRC-PC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

XELOX as first-line treatment regimen has limited efficacy against patients with metastatic colorectal cancer (mCRC). Peritoneal metastasis is one of the most lethal factor for mCRC. Intraperitoneal chemotherapy has became a widely accepted strategy in the treatment of peritoneal dissemination. We hypothesized that combined multi-channel administration, such as intraperitoneal chemotherapy, oral chemotherapy, and intravenous chemotherapy, can produce better results than XELOX for first-line treatment for mCRC patients.

Conditions

Colorectal Cancer Metastatic; Chemotherapy Effect; Chemotherapeutic Toxicity

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  PFS is the period between the first course of treatment to disease recurrence. The follow-up work will be performed every 6 weeks until disease recurrence or loss to follow-up.

  up to 1 year

Secondary Outcomes (3)

• Overall Survival (OS)

  up to 2 years

• Objective Response Rate (ORR)

  up to 24 weeks

• Adverse Events (AE)

  up to 2 years

Study Arms (2)

Multi-channel chemotherapy

EXPERIMENTAL

Patients will receive intraperitoneal irinotecan (50mg, d1, q2w).

Drug: Irinotecan

Control Group

ACTIVE COMPARATOR

Patients will receive intravenous oxaliplatin (130mg/m\^2, d1, q3w), and oral capecitabine (1.0g, d1-14, q3w).

Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Irinotecan DRUG

intraperitoneal

Multi-channel chemotherapy

Oxaliplatin DRUG

intravenous

Control Group

Capecitabine DRUG

Also known as: Oral

Control Group

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically confirmed adenocarcinoma of clorectal with inoperable locally advanced or metastatic disease, not amenable to curative therapy.
• Patients must have measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1), assessed using imaging techniques (CT or MRI).
• Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to chemotherapy, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 6 months after therapy completed Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1 or 2. Absolute neutrophil count (ANC) \>=1,500/ul Platelets (PLT) \>=75,000/ul Serum bilirubin \<= 1.5 × upper limit of normal (ULN) Aspartate transaminase (AST) or alanine aminotransferase (ALT) \<= 2.5 × ULN (or \<= 5 × ULN in patients with liver metastases) Alkaline phosphatase \<= 2.5 × ULN (or \<= 5 × ULN in patients with liver metastases, or \<= 10 × ULN in patients with bone but no liver metastases) Albumin \>= 25 g/L. Creatinine clearance \>= 60 mL/min. Life expectancy of at least 3 months. Signed informed consent.

You may not qualify if:

• Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study).
• Patients with active (significant or uncontrolled) gastrointestinal bleeding. Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity ≥ grade 2 NCI-CTCAE 4.0.
• Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
• History of documented congestive heart failure; angina pectoris requiring medication;evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
• Baseline left ventricular ejection fraction (LVEF) \< 50% (measured by echocardiography or MUGA).
• Patients with dyspnoea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
• Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).
• Clinically significant hearing abnormality. Known dihydropyrimidine dehydrogenase (DPD) deficiency. History or clinical evidence of brain metastases. Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
• Positive serum pregnancy test in women of childbearing potential. Received any investigational drug treatment within 4 weeks of start of study treatment.
• Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastatic site peripherally and patient recovered from any acute toxicity;prior adjuvant radiotherapy is allowed if complete at least 6 months ).
• Major surgery within 4 weeks of start of study treatment, without complete recovery.
• Patients with known active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV).
• Known hypersensitivity to any of the study drugs.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Comprehensive Cancer Center of Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Interventions

Irinotecan; Oxaliplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jing Jing

  The Comprehensive Cancer Center of Nanjing Drum Tower Hospital

  STUDY CHAIR

Central Study Contacts

Jing Hu, M.D., P.hD

CONTACT

0086-13057668736; doctorhujing@hotmail.com

Xiaoping Qian, M.D., P.hD

CONTACT

0086-13851763162; qianxiaoping211@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: investigator

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: January 3, 2019
• Study Start: January 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: January 3, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)