PLD Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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 Design
Arms and Interventions
| 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:
Drug: Cisplatin
cisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- disease control rate(DCR) [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.]
the rate of CR,PR and SD
Secondary Outcome Measures
- OS [From date of randomization until the date of death from any cause,assessed up to 18 months.]
overall survival
- 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.]
progression-free survival
- 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.]
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 [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.]
Evaluate the QoL according to Functional Assessment of Cancer Therapy.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Volunteer to participate and sign the informed consent form;
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Age :18-70 years old;
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Histopathologically confirmed inoperable advanced poorly differentiated thyroid carcinoma;
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Previously received surgery, I131 treatment, radiotherapy, chemotherapy patients can be enrolled；
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At least one measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST 1.1);
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Expected survival time ≥ 3 months;
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Karnofsky score ≥70;
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Blood test：ANC ≥1.5×109/L； PLT ≥75×109/L；Hb ≥90g/L;
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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;
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Renal function: Serum creatinine ≤ ULN 1.5times;
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LVEF ≥ 50%;
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No serious complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, noncancerous fever > 38℃;
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Subjects are well-behaved, able to undergo the follow-up efficacy and adverse reactions according to the program requirements.
Exclusion Criteria:
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Active or uncontrolled severe infection (≥CTCAE grade 2 infection)；
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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;
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The New York Heart Association (NYHA) graded class II or above heart disease patients previously or at present;
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Patients with CNS disorders or CNS metastases;
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Allergic to chemotherapeutic drugs or their excipients or intolerant patients;
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Received any other test drug treatment within 30 days of the first chemotherapy administration;
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Pregnant or lactating women;
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Arterial/venous thrombosis occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis, and pulmonary embolism;
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History of aneurysm;
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Neurological disorders with a history of epilepsy or ataxia require treatment;
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A history of drug abuse and incapable of abstinence or mental disorder;
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A history of peripheral neuropathy and the muscle strength is below level 3;
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Suffering from other diseases and complications of hand-foot syndrome;
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Researchers think it is not suitable for enrolling.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhejiang Cancer Hospital | Zhejiang | China |
Sponsors and Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
- Principal Investigator: minghua ge, doctor, Zhejiang Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSPC-DMS-CG-01