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

Phase 1 Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer

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

Study Overview

• Status: Unknown
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: "Apatinib" and "Capecitabine"; Drug: "Capecitabine"

Detailed Description

To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer,primary endpoint include in mPFS; secondary endpoint include in mOS, tolerance and security.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Informed consent form should be issued prior to conducting any research process;
2. Men or women aged 18-75 years;
3. Patients with advanced and / or metastatic colorectal cancer confirmed by histology or cytology;
4. Patients who has not exposed to apatinib previously and had received oxaliplatin combined with fluorouracil chemotherapy;
5. The estimated survival time is longer than 3 months;
6. ECOG score was 0 or 1;
7. 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;

8. 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)
9. Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before inclusion, the results should be negative and they are willing to use the appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration. Men should agree to use appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration;
10. Patients volunteered to participate in the trial and signed informed consent form with good compliance.

Exclusion Criteria:

1. 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;
2. With a variety of factors affecting oral drugs(such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.);
3. 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;
4. Abnormal coagulation function(INR>1.5×ULN、 APTT>1.5×ULN) with bleeding tendency;
5. With Symptomatic central nervous system metastasis;
6. Pregnant or lactating women;
7. Other patients unsuitable for inclusion considered by the physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: "apatinib" and "capecitabine"; Arm A: "apatinib" and "capecitabine" apatinib 250mg qdpo; capecitabine 1000mg/m2 qdpo d1-14 q3w	Drug: "Apatinib" and "Capecitabine"; Combine "Apatinib" and "Capecitabine" to Maintain Treating Metastatic Colorectal Cancer; Other Names: Arm A
Active Comparator: B: "capecitabine" single drug; Arm B: "capecitabine" single drug "capecitabine" 1000mg/m2 qdpo d1-14 q3w	Drug: "Capecitabine"; Single Drug "Capecitabine" to Maintain Treating Metastatic Colorectal Cancer; Other Names: Arm B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yanqiao Zhang

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2017
• Primary Completion (Anticipated): February 28, 2018
• Study Completion (Anticipated): April 30, 2018

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Capecitabine; Apatinib; Metastatic Colorectal Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Protein Kinase Inhibitors; Capecitabine; Apatinib
• Other Study ID Numbers: 045186298222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No