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

NCT03387943 | Unknown Phase 2

• 1 other identifier: CSPC-DMS-CG-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Poorly Differentiated Thyroid Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• OS

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

• PFS

  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.

  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

  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.

Study Arms (1)

PLD plus Cisplatin

EXPERIMENTAL

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; Drug: Cisplatin

Interventions

PLD DRUG

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

Also known as: duomeisu

PLD plus Cisplatin

Cisplatin DRUG

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

Also known as: shunbo

PLD plus Cisplatin

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Zhejiang Cancer Hospital

Zhejiang, China

RECRUITING

MeSH Terms

Interventions

1-dodecylpyridoxal; Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• minghua ge, doctor

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jiandong nie, doctor

CONTACT

0311-66575708; niejd@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 2, 2018
• Study Start: March 6, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: January 3, 2018

Record last verified: 2017-02

Locations

CN (1)