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Gemcitabine and Carboplatin in Metastatic or Recurrent Nasopharyngeal Carcinoma
NCT00697905Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2008
- Primary completion
- May 2011
- Countries
- 1
- Sponsor
- Ministry of Health Malaysia
- Modality
- DNA Intercalators/Alkylators
- Conditions
- nasopharyngeal carcinoma (NPC)
01
Overview
Phase 2, randomised, open-label trial of gemcitabine and carboplatin in nasopharyngeal carcinoma (NPC) (2 arms), sponsored by Ministry of Health Malaysia. Primary endpoint: Response to Therapy at 12 months. Started Jan 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Gemcitabine + Carboplatin
Gemcitabine IV days 1, 8 + Carboplatin IV day 1, every 21 days
Cisplatin + 5-FU
Cisplatin IV day 1 + 5-FU IV days 2-5, every 28 days
03
Who it enrols
Patients with histologically proven recurrent or metastatic nasopharyngeal carcinoma, measurable disease, ECOG 0-2, and adequate organ function. Excludes pregnant women, prior gemcitabine use, brain metastases, bone-only metastases, and severe hearing loss.
04
Endpoints
Primary
Response to Therapy
Secondary
Progression Free Survival
Duration of Response
Safety and Tolerability
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