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

NCT ID: NCT03387943

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-06
• Study Completion Date: 2019-12-31

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).

Conditions

Poorly Differentiated Thyroid Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PLD

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

Interventions

PLD

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

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Other Intervention Names

duomeisu; shunbo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

minghua ge, doctor

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Zhejiang, , China

Site Status: RECRUITING

Countries

China

Central Contacts

jiandong nie, doctor

Role: CONTACT

niejd@mail.ecspc.com

0311-66575708

Facility Contacts

haiyan yang, doctor

Role: primary

Other Identifiers

CSPC-DMS-CG-01

Identifier Type: -

Identifier Source: org_study_id