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Trial record 4 of 430 for:    colon cancer AND Capecitabine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03132025
Recruitment Status : Unknown
Verified April 2017 by Yanqiao Zhang, Harbin Medical University.
Recruitment status was:  Not yet recruiting
First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Yanqiao Zhang, Harbin Medical University

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

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: "Apatinib" and "Capecitabine" Drug: "Capecitabine" Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer
Estimated Study Start Date : April 30, 2017
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Arm B




Primary Outcome Measures :
  1. Progression-free Survival of Patients with Apatinib and Capecitabine Combination That is prolonged [ Time Frame: up to 10 months ]
    Patients with double drug group have more longer progression-free survival (PFS) than patients with single drug group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Yanqiao Zhang, Head of Gastroenterology, Harbin Medical University
ClinicalTrials.gov Identifier: NCT03132025     History of Changes
Other Study ID Numbers: 045186298222
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Yanqiao Zhang, Harbin Medical University:
Metastatic Colorectal Cancer
Apatinib
Capecitabine

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Apatinib
Benzocaine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Protein Kinase Inhibitors
Enzyme Inhibitors