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

NCT04358341 | Unknown Phase 2 DMC

• 1 other identifier: SAHMO205
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Pegliposomal Doxorubicin

Outcome Measures

Primary Outcomes (1)

• Disease control rate (DCR)

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

  24 weeks

Secondary Outcomes (5)

• Objective response rate (ORR)

  24 weeks

• Progression-Free Survival (PFS)

  1 year

• Overall Survival (OS)

  2 years

• Treatment associated toxicities

  2 years

• EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores

  2 years

Study Arms (2)

Irinotecan alone

ACTIVE COMPARATOR

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

Drug: Irinotecan

Pegliposomal Doxorubicin and 5-FU

EXPERIMENTAL

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

Drug: DOXOrubicin Liposome Injection; Drug: 5fluorouracil

Interventions

Irinotecan DRUG

150 mg/m2 ivdrip every 14 days

Also known as: CPT-11

Irinotecan alone

DOXOrubicin Liposome Injection DRUG

25 mg/m2 ivdrip every 14 days

Also known as: Pegliposomal Doxorubicin

Pegliposomal Doxorubicin and 5-FU

5fluorouracil DRUG

400mg/m2 iv bolus and 2400 mg/m2 civ 46h every 14 days

Also known as: 5-FU

Pegliposomal Doxorubicin and 5-FU

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Jian Xiao

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Irinotecan; Doxorubicin; Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jian Xiao, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohui Zhai, MD

CONTACT

862038285497; zhaixh@mail.sysu.edu.cn

Shanshan Li

CONTACT

862038285497; lishsh89@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asso. Professor

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 24, 2020
• Study Start: June 17, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 24, 2020

Record last verified: 2020-08

Locations

CN (1)