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

Primary Purpose

Poorly Differentiated Thyroid Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

PLD

Cisplatin

About this trial

This is an interventional treatment trial for Poorly Differentiated Thyroid Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

Volunteer to participate and sign the informed consent form;
Age :18-70 years old;
Histopathologically confirmed inoperable advanced poorly differentiated thyroid carcinoma;
Previously received surgery, I131 treatment, radiotherapy, chemotherapy patients can be enrolled；
At least one measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST 1.1);
Expected survival time ≥ 3 months;
Karnofsky score ≥70;
Blood test：ANC ≥1.5×109/L； PLT ≥75×109/L；Hb ≥90g/L;
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;
Renal function: Serum creatinine ≤ ULN 1.5times;
LVEF ≥ 50%;
No serious complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, noncancerous fever > 38℃;
Subjects are well-behaved, able to undergo the follow-up efficacy and adverse reactions according to the program requirements.

Exclusion Criteria:

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

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PLD plus Cisplatin

Arm Description

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.

Outcomes

Primary Outcome Measures

disease control rate(DCR)

the rate of CR,PR and SD

Secondary Outcome Measures

overall survival

PFS

progression-free survival

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.

quality of life assessment

Evaluate the QoL according to Functional Assessment of Cancer Therapy.

Full Information

NCT ID

NCT03387943

First Posted

December 11, 2017

Last Updated

January 2, 2018

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03387943

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 6, 2017 (Actual)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Poorly Differentiated Thyroid Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PLD plus Cisplatin

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

PLD

Other Intervention Name(s)

duomeisu

Intervention Description

intravenous infusion of liposomal doxorubicin 35 mg/m2, d1,once every 21days, for 6 cycles.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

shunbo

Intervention Description

cisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles.

Primary Outcome Measure Information:

Title

disease control rate(DCR)

Description

the rate of CR,PR and SD

Time Frame

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 Measure Information:

Title

Description

overall survival

Time Frame

From date of randomization until the date of death from any cause,assessed up to 18 months.

Title

PFS

Description

progression-free survival

Time Frame

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.

Title

Incidence of adverse events assessed by number and severity of adverse event in the treatment.

Description

Evaluate the adverse reaction rate of drugs assessed by number and severity of adverse events in the treatment of advanced thyroid poorly differentiated carcinoma.

Time Frame

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.

Title

quality of life assessment

Description

Evaluate the QoL according to Functional Assessment of Cancer Therapy.

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Volunteer to participate and sign the informed consent form; Age :18-70 years old; Histopathologically confirmed inoperable advanced poorly differentiated thyroid carcinoma; Previously received surgery, I131 treatment, radiotherapy, chemotherapy patients can be enrolled； At least one measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST 1.1); Expected survival time ≥ 3 months; Karnofsky score ≥70; Blood test：ANC ≥1.5×109/L； PLT ≥75×109/L；Hb ≥90g/L; 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; Renal function: Serum creatinine ≤ ULN 1.5times; LVEF ≥ 50%; No serious complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, noncancerous fever > 38℃; Subjects are well-behaved, able to undergo the follow-up efficacy and adverse reactions according to the program requirements. Exclusion Criteria: Active or uncontrolled severe infection (≥CTCAE grade 2 infection)； 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; The New York Heart Association (NYHA) graded class II or above heart disease patients previously or at present; Patients with CNS disorders or CNS metastases; Allergic to chemotherapeutic drugs or their excipients or intolerant patients; Received any other test drug treatment within 30 days of the first chemotherapy administration; Pregnant or lactating women; Arterial/venous thrombosis occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis, and pulmonary embolism; History of aneurysm; Neurological disorders with a history of epilepsy or ataxia require treatment; A history of drug abuse and incapable of abstinence or mental disorder; A history of peripheral neuropathy and the muscle strength is below level 3; Suffering from other diseases and complications of hand-foot syndrome; Researchers think it is not suitable for enrolling.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

jiandong nie, doctor

Phone

0311-66575708

niejd@mail.ecspc.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

minghua ge, doctor

Organizational Affiliation

Zhejiang Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Zhejiang

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

haiyan yang, doctor

12. IPD Sharing Statement

Learn more about this trial

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

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