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Pegliposomal Doxorubicin and 5-fluorouracil as Second Line Therapy for Metastatic Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Irinotecan
DOXOrubicin Liposome Injection
5fluorouracil
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Pegliposomal Doxorubicin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-70 years old;
  2. Metastatic gastric cancer progressed on first-line treatment;
  3. Expected survival time ≥ 3 months;
  4. At least one evaluable target lesion according to the solid tumor evaluation criteria (RECIST) version 1.1;
  5. ECOG PS 0~2;
  6. Adequate bone marrow function reserve: white blood cell count ≥ 3.0 × 10*9 / L, neutrophil count ≥ 1.5 × 10*9/ L; platelet count ≥ 100 ×10*9/ L; hemoglobin ≥ 90 g / L;
  7. Adequate liver and renal function reserve: AST and ALT ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 2 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value;
  8. LVEF ≥ 55 %;
  9. Be able to understand the research process, volunteer to participate in the study, and sign an informed consent form.

Exclusion Criteria:

  1. Patients known to be allergic to active or other components of chemotherapeutic drugs;
  2. Patients who have been treated with PLD or irinotecan in the past;
  3. According to the researcher's judgment, other anti-tumor treatments such as radiotherapy and surgical resection are required during chemotherapy;
  4. Those who are not expected to be able to tolerate chemotherapy with severe heart disease or discomfort;
  5. d-MMR or MSI-H or Her-2 overexpression;
  6. Severe or uncontrolled infections or diabetes;
  7. History of other malignacis in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin);
  8. Participated in other clinical trials within 4 weeks prior to the start of the study;
  9. Pregnant or lactating women, or women of childbearing age who refuse to take effective contraception during the study.

Sites / Locations

  • Jian XiaoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Irinotecan alone

Pegliposomal Doxorubicin and 5-FU

Arm Description

150 mg/m2 iv drip d1; Repeat every 14 days.

Pegliposomal Doxorubicin: 25mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ 46h d1; Repeat every 14 days.

Outcomes

Primary Outcome Measures

Disease control rate (DCR)
Percentage of subjects with tumor shrinkage reaching complete response (CR), partial response (PR) and disease stabilization (SD).

Secondary Outcome Measures

Objective response rate (ORR)
Percentage of subjects with tumor shrinkage reaching complete response (CR) and partial remission (PR).
Progression-Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log or the date of last follow-up.
Treatment associated toxicities
According to WHO CTC 3.0
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
The QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.

Full Information

First Posted
April 13, 2020
Last Updated
August 21, 2020
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04358341
Brief Title
Pegliposomal Doxorubicin and 5-fluorouracil as Second Line Therapy for Metastatic Gastric Cancer
Official Title
Phase II Study of Pegliposomal Doxorubicin and 5-fluorouracil Compared With Irinotecan as Second Line Therapy for Metastatic Gastric Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
For second-line chemotherapy for metastatic gastric cancer, single-agent irinotecan is the standard treatment. Anthracyclines are active but lack well designed investigations. The combination of epirubicin, fluorouracil and cisplatin (or oxaliplatin) are widely used in Europe. However, traditional anthracyclines are more cardiotoxic; and (Pegliposomal Doxorubicin) PLD, as a new liposome dosage form of doxorubicin, has better cardiac safety. Therefore, we designed this phase II trial with PLD and 5-Fu to compare irinotecan monotherapy in the second-line treatment.
Detailed Description
Patients with metastatic gastric cancer failed to first-line therapy will be radomized to arm A with PLD and 5-Fu and arm B with irinotecan single agent therapy. Both regimens will be treated every 2 weeks until disease progression or untolerable toxicity. Efficacy will be assessed every 3 cycles and safety will be evaluated every cycle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Pegliposomal Doxorubicin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Irinotecan alone
Arm Type
Active Comparator
Arm Description
150 mg/m2 iv drip d1; Repeat every 14 days.
Arm Title
Pegliposomal Doxorubicin and 5-FU
Arm Type
Experimental
Arm Description
Pegliposomal Doxorubicin: 25mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ 46h d1; Repeat every 14 days.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
CPT-11
Intervention Description
150 mg/m2 ivdrip every 14 days
Intervention Type
Drug
Intervention Name(s)
DOXOrubicin Liposome Injection
Other Intervention Name(s)
Pegliposomal Doxorubicin
Intervention Description
25 mg/m2 ivdrip every 14 days
Intervention Type
Drug
Intervention Name(s)
5fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
400mg/m2 iv bolus and 2400 mg/m2 civ 46h every 14 days
Primary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
Percentage of subjects with tumor shrinkage reaching complete response (CR), partial response (PR) and disease stabilization (SD).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Percentage of subjects with tumor shrinkage reaching complete response (CR) and partial remission (PR).
Time Frame
24 weeks
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.
Time Frame
1 year
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log or the date of last follow-up.
Time Frame
2 years
Title
Treatment associated toxicities
Description
According to WHO CTC 3.0
Time Frame
2 years
Title
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Description
The QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-70 years old; Metastatic gastric cancer progressed on first-line treatment; Expected survival time ≥ 3 months; At least one evaluable target lesion according to the solid tumor evaluation criteria (RECIST) version 1.1; ECOG PS 0~2; Adequate bone marrow function reserve: white blood cell count ≥ 3.0 × 10*9 / L, neutrophil count ≥ 1.5 × 10*9/ L; platelet count ≥ 100 ×10*9/ L; hemoglobin ≥ 90 g / L; Adequate liver and renal function reserve: AST and ALT ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 2 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value; LVEF ≥ 55 %; Be able to understand the research process, volunteer to participate in the study, and sign an informed consent form. Exclusion Criteria: Patients known to be allergic to active or other components of chemotherapeutic drugs; Patients who have been treated with PLD or irinotecan in the past; According to the researcher's judgment, other anti-tumor treatments such as radiotherapy and surgical resection are required during chemotherapy; Those who are not expected to be able to tolerate chemotherapy with severe heart disease or discomfort; d-MMR or MSI-H or Her-2 overexpression; Severe or uncontrolled infections or diabetes; History of other malignacis in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin); Participated in other clinical trials within 4 weeks prior to the start of the study; Pregnant or lactating women, or women of childbearing age who refuse to take effective contraception during the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohui Zhai, MD
Phone
862038285497
Ext
862038285497
Email
zhaixh@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shanshan Li
Phone
862038285497
Ext
862038285497
Email
lishsh89@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Xiao, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jian Xiao
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Xiao, MD
Phone
862038285497
Ext
862038285497
Email
xiaoj26@mail.sysu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Pegliposomal Doxorubicin and 5-fluorouracil as Second Line Therapy for Metastatic Gastric Cancer

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