PLD Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma

A Prospective, Multicenter, Open Label Phase Ⅱ Clinical Trial of Doxorubicin Hydrochloride Liposome Injection Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma

This is a prospective, multicenter, open label Phase II Clinical Trial. 30 advanced poorly differentiated thyroid carcinoma patients who were histopathologically confirmed inoperable were enrolled in this study.

Study Overview

• Status: Unknown
• Conditions: Poorly Differentiated Thyroid Carcinoma
• Intervention / Treatment: Drug: PLD; Drug: Cisplatin

Detailed Description

Subjects will receive the treatment regimen as follow:

intravenous infusion of liposomal doxorubicin 35 mg/m2, d1; cisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles. Stop the treatment if the patients have progressed or intolerated to the toxicity. The primary endpoint is disease control rate(DCR), the secondary endpoint is overall survival (OS), progression-free survival (PFS), safety and quality of life assessment(QoL).

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang, China
    • Recruiting
    • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Volunteer to participate and sign the informed consent form;
2. Age :18-70 years old;
3. Histopathologically confirmed inoperable advanced poorly differentiated thyroid carcinoma;
4. Previously received surgery, I131 treatment, radiotherapy, chemotherapy patients can be enrolled；
5. At least one measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST 1.1);
6. Expected survival time ≥ 3 months;
7. Karnofsky score ≥70;
8. Blood test：ANC ≥1.5×109/L； PLT ≥75×109/L；Hb ≥90g/L;
9. Liver function:Serum bilirubin (SB) level:≤ normal upper limit（ULN）2 times; aspartate aminotransferase(AST) and alanine aminotransferase(ALT) ≤ ULN 2.5times; or ≤ ULN 5times if Liver metastases are present;
10. Renal function: Serum creatinine ≤ ULN 1.5times;
11. LVEF ≥ 50%;
12. No serious complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, noncancerous fever > 38℃;
13. Subjects are well-behaved, able to undergo the follow-up efficacy and adverse reactions according to the program requirements.

Exclusion Criteria:

1. Active or uncontrolled severe infection (≥CTCAE grade 2 infection)；
2. Previously received anthracycline-based regimen: the cumulative dose of doxorubicin at or above 500 mg / m2 or the cumulative dose of epirubicin reached or exceeded 800 mg / m2;
3. The New York Heart Association (NYHA) graded class II or above heart disease patients previously or at present;
4. Patients with CNS disorders or CNS metastases;
5. Allergic to chemotherapeutic drugs or their excipients or intolerant patients;
6. Received any other test drug treatment within 30 days of the first chemotherapy administration;
7. Pregnant or lactating women;
8. Arterial/venous thrombosis occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis, and pulmonary embolism;
9. History of aneurysm;
10. Neurological disorders with a history of epilepsy or ataxia require treatment;
11. A history of drug abuse and incapable of abstinence or mental disorder;
12. A history of peripheral neuropathy and the muscle strength is below level 3;
13. Suffering from other diseases and complications of hand-foot syndrome;
14. Researchers think it is not suitable for enrolling.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PLD plus Cisplatin; liposomal doxorubicin(PLD) 35 mg/m2,iv,d1, plus cisplatin 75 mg/m2,drip,d1-3, once every 21days, for 6 cycles, to progression or intolerance.	Drug: PLD; intravenous infusion of liposomal doxorubicin 35 mg/m2, d1,once every 21days, for 6 cycles.; Other Names: duomeisu; Drug: Cisplatin; cisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles.; Other Names: shunbo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease control rate(DCR)	the rate of CR,PR and SD	disease control rate will be evaluated every 2 cycles (each cycle is 21 days) from date of administration of drugs until the date of first documented progression，up to 18 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival	From date of randomization until the date of death from any cause,assessed up to 18 months.
PFS	progression-free survival	From date of randomization until the date of first documented disease progression or date of death from any case,whichever came first,assessed up to 18 months.
Incidence of adverse events assessed by number and severity of adverse event in the treatment.	Evaluate the adverse reaction rate of drugs assessed by number and severity of adverse events in the treatment of advanced thyroid poorly differentiated carcinoma.	A summary of adverse events of each cycle,from date of administration of drugs until 30 days after the last chemotherapy or progression,whichever came first,assessed up to 18 months.
quality of life assessment	Evaluate the QoL according to Functional Assessment of Cancer Therapy.	It will be assessed before the administration of drugs at each first day of the chemotherapy cycle,up to 6 cycles,each cycle is 21 days.

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Investigators: Principal Investigator: minghua ge, doctor, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2017
• Primary Completion (ANTICIPATED): December 31, 2018
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (ACTUAL): January 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Carcinoma; Thyroid Diseases; Thyroid Neoplasms; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: CSPC-DMS-CG-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No