Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia

January 28, 2019 updated by: Zhu Ji, Fudan University

A Randomized Phase II Study of Recombinant Human Thrombopoietin (Rh-TPO) and Recombinant Human Interleukin-11 (rhIL-11) for Recurrent Colorectal Cancer (CRC) Patients With Thrombocytopenia

This randomized controlled clinical phase II study was designed to compare the effect of rhTPO with rhIL-11 in improving thrombocytopenia in patients with recurrent colorectal cancer who underwent radiotherapy and with thrombocytopenia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Most patients with recurrent CRC have undergone a six-month postoperative adjuvant chemotherapy with oxaliplatin plus fluorouracil. Although the main dose-limiting side effect of oxaliplatin is neurotoxicity, with the widespread use of this drug, there are more and more reports that oxaliplatin is discontinued because of thrombocytopenia, which increases the risk of bleeding, rate of blood transfusion needs and length of stay. On the other hand, patients undergoing pelvic radiotherapy may also experience significant bone marrow suppression because flat bones such as the tibia may be exposed to high doses radiation. Low platelet counts is an urgent problem to be solved in order to give adequate quantitative radiotherapy. This randomized controlled clinical phase II study was designed to compare the effect of rhTPO with rhIL-11 in improving thrombocytopenia in patients with recurrent colorectal cancer who underwent radiotherapy and with thrombocytopenia, thus providing more evidence in clinical practice.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • The primary tumor is colorectal cancer, histologically proved recurrence or metastasis disease, or pelvic relapse within 6 months after oxaliplatin-based adjuvant chemotherapy.
  • Not suitable for re-use of oxaliplatin and fluorouracil.
  • No medication history of irinotecan.
  • Lesions evaluable, and has indications for radiotherapy.
  • UGT1A1*28 gene phenotype is 6/6 or 6/7
  • Karnofsky physical condition score ≥ 70
  • Baseline platelet counts are 25-75×10^9/L, other bone marrow reserve and liver and kidney function meet the requirements of radiotherapy
  • Able to follow the program during the study period
  • Sign the informed consent

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ
  • If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
  • Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
  • Organ transplantation requires immunosuppressive therapy
  • Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
  • Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin ≥ 30g / L
  • Anyone who is allergic to any research medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rhTPO arm

rhTPO: 300 u/kg, subcutaneous injection, per day. (stopped as soon as the platelet count rises to normal)

Concurrent Chemoradiotherapy:

Radiation: judged according to the tumor site and radiotherapy purpose.

Irinotecan: 80 mg/m2 (UGT1A1*28 6/6) or 65 mg/m2 (UGT1A1*28 6/7)

Raltitrexed: 3 mg/m2 q3w
Drug: rhTPO
rhTPO 300u/kg, subcutaneous injection, qd
Drug: irinotecan
80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
Drug: Raltitrexed
3mg/m2 q3w
Radiation: radiotherapy
in the use of intensity-modulated radiotherapy (IMRT) technology, the dose is judged according to the tumor site and radiotherapy purpose.
Active Comparator: rhIL-11 arm

rhIL-11: 50 ug/kg, subcutaneous injection, per day. (stopped as soon as the platelet count rises to normal)

Concurrent Chemoradiotherapy:

Radiation: judged according to the tumor site and radiotherapy purpose.

Irinotecan: 80 mg/m2 (UGT1A1*28 6/6) or 65 mg/m2 (UGT1A1*28 6/7)

Raltitrexed: 3 mg/m2 q3w
Drug: irinotecan
80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
Drug: Raltitrexed
3mg/m2 q3w
Radiation: radiotherapy
in the use of intensity-modulated radiotherapy (IMRT) technology, the dose is judged according to the tumor site and radiotherapy purpose.
Drug: rhIL-11
rhIL-11 50ug/kg, subcutaneous injection, qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the rate of recovery of platelet accounts
Time Frame: From date of chemoradiation until the date of first documented recovery, assessed up to 6 months
From date of chemoradiation until the date of first documented recovery, assessed up to 6 months
the duration after returning to normal
Time Frame: From date of first documented recovery until the date of first documented decrease of platelet accounts, assessed up to 6 months
From date of first documented recovery until the date of first documented decrease of platelet accounts, assessed up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cycles of concurrent chemotherapy patients received during radiotherapy
Time Frame: through chemoradiation, an average of 5 weeks
through chemoradiation, an average of 5 weeks
change of participant quality of life during treatment as assessed by EORTC-quality of life questionnaire-C30
Time Frame: at the beginning and the end of chemoradiation.
at the beginning and the end of chemoradiation.
change of participant quality of life during treatment as assessed by EuroQol-5 dimensional (EQ-5D) questionnaire
Time Frame: at the beginning and the end of chemoradiation.
at the beginning and the end of chemoradiation.
the rate of pathological complete response.
Time Frame: Surgery scheduled 6-8 weeks after the end of chemoradiation
pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.
Surgery scheduled 6-8 weeks after the end of chemoradiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Study Chair: Zhen Zhang, MD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2019

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

January 19, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDRT-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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