The effectiveness and safety of lobaplatin combined with docetaxel for recrudescent and metastatic nasopharyngeal carcinoma: a prospective, non-controlled, multi-center clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONC-11001497

Enrollment

Unknown

Registered

2011-08-30

Start date

2011-04-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nasopharyngeal carcinoma

Interventions

LBP+DTX:Day 1: Docetaxel 75mg/m2/day

Day 2: lobaplatin 30mg/m2/day. Each therapy cycle consists of 21 days. Maximun: 6 cycles

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 70 years old; male or female patients; 2. With the diagnosis of the phase of II, III nasopharyngeal carcinoma confirmed by pathological or cytology tests; 3. Patients with recrudescent and metastatic nasopharyngeal carcinoma; 4. With measurable metastasis foci; 5. ECOG PS: 0 or 1; 6. Life expectancy >=3 months; 7. Laboratory parameters: Bone marrow function: WBC>=4.0*10^9/L, ANC>=1.5*10^9/L; PLT>=100*10^9/L; HB>=90g/L; Hepatic function: STB, CB<=ULN*1.5; ALT and AST<=ULN*1.5; Renal function: Cr<=ULN; Coagulation function: PT INR) <=ULN*1.5; 8. Without the malignant tumor of other tissue(excluding cerical cancer, basal cell carcinoma or squamous carcinoma); 9. Without other anti-cancer therapy (including steroids); 10. Without other serious disease limitted in the trial; 11. Voluntary to participate and sign informed consent document.

Exclusion criteria

Exclusion criteria: 1. Allergic to platinum drugs used in the trial; 2. Have received the docetaxel therapy within the latest 6 monthes; 3. Have received surgical intervention or ratiotherapy within the latest 4weeks; 4. The patients with acute severe infection; 5. With the damage of cerebrospinal by ratiotherapy; 6. Have the previous anti-cancer treatment toxicity (>=CTCAE 3); 7. Have the malignant tumor of other tissue within 5 years (excluding cerical cancer, basal cell carcinoma or squamous carcinoma); 8. Severe cardiaovascular diseases including uncontrolled hypertension, unstable angina pectoris, cardiac infarction, heart failure (>2 according to NYHA standard) and severe cardiac arrhythmia; 9. History of hemorrhage (>=CTCAE 3) within the latest 4 weeks; 10. Patients needing anticoagulation therapy or vitamin K antagonists (excluding prevention use of small dosage of warfarin<=1mg/d and aspirin<=100mg/d ); 11. Have participated in other drug trial within the latest 4 weeks; 12. Pregnant or breast-feeding women; or women planning to get pregnant; 13. The patients with mental disease.

Design outcomes

Primary

Measure	Time frame
Objective response rate;Disease control rate;	—

Secondary

Measure	Time frame
Safety;Progression-free survival;Overall survival;	—

Countries

China

Contacts

Public ContactDonghu Sui

suidonghu@sohu.com+86 13891830831

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026