Weekly Docetaxel Plus Cisplatin as First-line Chemotherapy in Metastatic Salivary Gland Cancer Patients : a Multicenter Phase II Study

NCT05008237 | Unknown Phase 2

• 1 other identifier: 2013-07-149
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Cisplatin plus weekly docetaxel as first-line chemotherapy in metastatic salivary gland cancer patients : a multicenter phase II study

Conditions

Salivary Gland Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate

  To evaluate the effectiveness of regimen. The overall response rate will be measured by RECIST v1.1.

  Up to 30months

Secondary Outcomes (3)

• Overall survival (OS)

  The time until defineded by date of all-cause mortality from date of IP administration. Up to 30 months.

• progression-free survival (PFS)

  The time until the date of either disease progression or the all cause mortality from the date of IP administration. Up to 30months.

• Adeverse event(AE)

  from the date of informed consent signature to 21days after last drug administration.

Study Arms (1)

Cisplatin plus docetaxel

EXPERIMENTAL

D1, D8 Docetaxel 35 mg/m2 + D5W 100mL MIV over 1hr D1 Cisplatin 70mg/m2 + NS 150mL MIV over 1hr every 3 weeks Treatment will be continued until disease progression or unacceptable toxic effects.

Drug: docetaxel plus Cisplatin

Interventions

docetaxel plus Cisplatin DRUG

D1, D8 Docetaxel 35 mg/m2 + D5W 100mL MIV over 1hr D1 Cisplatin 70mg/m2 + NS 150mL MIV over 1hr every 3 weeks Treatment will be continued until disease progression or unacceptable toxic effects.

Cisplatin plus docetaxel

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-confirmed salivary gland cancer with one of the following histologic subtypes : mucoepidermoid, adenocarcinoma/ductal carcinoma or adenoid cystic carcinoma
• Only progressive disease in case of ACC
• Progressive disease is defined as one of the following occurring within 6 months of study entry (i) at least a 20% increase in radiologically or clinically measurable disease, (ii) appearance of new lesions or (iii) deterioration in clinical status
• stage IV or recurrent cancer which is incurable with surgery or radiotherapy
• age ≥ 20 years
• ECOG performance status 0-1 ⑥ At least one measurable tumor lesion according to RECIST 1.1
• Expected survival for approximately 12 weeks or longer
• ⑧ No prior systemic chemotherapy (Patients who received adjuvant chemotherapy or chemoradiotherapy completed more than 6 months before will be eligible)
• At least 4 weeks later after major surgery or radiotherapy ⑩ Organ function as evidence by the following; WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3, ANC ≥ 1,500 cells/mm3, Hemoglobin ≥ 10 g/dL (transfusion allowed), Platelet count ≥ 100,000 plts/mm3; Total bilirubin ≤ 1.5 ULN AST/ALT ≤ 2.5 ULN, (if liver metastases: AST, ALT ≤5.0 x ULN); Creatinine clearance 50 mL/min or serum creatinine ≤ 1.5 x UNL ⑪ Written informed consent

You may not qualify if:

• Severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal medication and/or coronary angioplasty (including stent placement) within the preceding 24 months (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
• Uncontrolled systemic illness such as DM, hypertension, hypothyroidism and infection
• Pregnant and nursing women (women of reproductive potential have to agree to use an effective contraceptive method) ④ Symptomatic CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery allowed) ⑤ Patients with alcohol abuse

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnamgu, 06351, South Korea

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: August 17, 2021
• Study Start: May 2, 2014
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2023
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

KR (1)