Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer

NCT03132025 | Unknown Phase 2 DMC

• 1 other identifier: 045186298222
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer.

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer; Apatinib; Capecitabine

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival of Patients with Apatinib and Capecitabine Combination That is prolonged

  Patients with double drug group have more longer progression-free survival (PFS) than patients with single drug group

  up to 10 months

Study Arms (2)

A: "apatinib" and "capecitabine"

EXPERIMENTAL

Arm A: "apatinib" and "capecitabine" apatinib 250mg qdpo; capecitabine 1000mg/m2 qdpo d1-14 q3w

Drug: "Apatinib" and "Capecitabine"

B: "capecitabine" single drug

ACTIVE COMPARATOR

Arm B: "capecitabine" single drug "capecitabine" 1000mg/m2 qdpo d1-14 q3w

Drug: "Capecitabine"

Interventions

"Apatinib" and "Capecitabine" DRUG

Combine "Apatinib" and "Capecitabine" to Maintain Treating Metastatic Colorectal Cancer

Also known as: Arm A

A: "apatinib" and "capecitabine"

"Capecitabine" DRUG

Single Drug "Capecitabine" to Maintain Treating Metastatic Colorectal Cancer

Also known as: Arm B

B: "capecitabine" single drug

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent form should be issued prior to conducting any research process;
• Men or women aged 18-75 years;
• Patients with advanced and / or metastatic colorectal cancer confirmed by histology or cytology;
• Patients who has not exposed to apatinib previously and had received oxaliplatin combined with fluorouracil chemotherapy;
• The estimated survival time is longer than 3 months;
• ECOG score was 0 or 1;
• According to the RECIST v1.1 guidance, at least 1 lesion(who had not received radiotherapy) showed that the longest diameter≥10mm(except for lymph node, the short axis of the lymph node must be≥15mm) through CT or MRI(intravenous contrast agent was preferred ) accurate measurement and the lesion should be suitable for repeatable and accurate measurement; the lesion located in the previously irradiated area can be used as a measurable lesion if the lesion was proved in progress;
• With sufficient organ and bone marrow function, defined as follows:
• Hb≥9 g/dL
• Absolute neutrophil count ≥1.0 × 109 /L
• Platelet count≥75 × 109 /L
• Serum bilirubin ≤ 1.5 × ULN, which would not be appropriate for patients with Gilbert syndrome (Persistent or recurrent hyperbilirubinemia, mainly unconjugated bilirubin, with no evidence of hemolysis or abnormal liver pathology) which can consult a doctor
• ALT\&AST ≤ 2.5 × ULN; for patients with liver metastases, ALT\&AST ≤ 5 × ULN Calculate the creatinine clearance rate by Cockcroft-Gault formula
• Creatinine clearance rate measured( by actual body weight) or by measuring urine collection for 24 hours\> 40 mL/min(the value of the measurement of the 24 - hour urine collection will be used to determine eligibility if the two methods are used)
• Patients volunteered to participate in the trial and signed informed consent form with good compliance.

You may not qualify if:

• Patients with hypertension and can not be reduced to the normal range with antihypertensive drugs(systolic pressure \>140 mmHg / diastolic pressure \> 90 mmHg),patients with coronary heart disease more than grade II, arrhythmia (including QTc interval Prolongation men\>450 ms, women \>470 ms) and cardiac insufficiency;
• With a variety of factors affecting oral drugs(such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.);
• Special note: patients with the risk of gastrointestinal bleeding can not be included, including the following: active peptic ulcer lesions and fecal occult blood (+ +); patients with melena and hematemesis in 3 months; for patients with fecal occult blood (+) and primary gastric tumor without surgery should be carried out gastroscopy, patients with ulcero carcinoma of stomach and believed to cause the lesion to bleed by the physician;
• Abnormal coagulation function(INR\>1.5×ULN、 APTT\>1.5×ULN) with bleeding tendency;
• With Symptomatic central nervous system metastasis;
• Pregnant or lactating women;

Sponsors & Collaborators

• Yanqiao Zhang: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

apatinib; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

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

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: SPONSOR INVESTIGATOR
• PI Title: Head of Gastroenterology

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: April 27, 2017
• Study Start: April 30, 2017
• Primary Completion: February 28, 2018
• Study Completion: April 30, 2018
• Last Updated: April 27, 2017

Record last verified: 2017-04