Phase I Study of Olaparib With Cisplatin Based Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck

Sponsor
University College, London
Study ID
NCT01491139
Phase
PHASE1
Status
Withdrawn

Conditions

  • Carcinoma, Squamous Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • olaparib — DRUG
    Given twice daily. Exposure will escalate by daily dose and duration.
  • cisplatin — DRUG
    Dose will be 35mg/m2 i.v. once weekly.
  • Intensity Modulated Radiotherapy — RADIATION
    Total dose will be 70Gy in 35 fractions over 7 weeks.

Study Details

The aim of this study is to find the safe dose and best dosing schedule of olaparib to give in combination with cisplatin based chemoradiotherapy (CRT) in patients with locally advanced head and neck cancer. The dose decided on in this part of the study will become the recommended dose for the randomised Phase II trial.

Key Dates

Status verified
May 2012

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: single arm
    All patients will receive induction chemotherapy (cisplatin and 5-FU), followed by cisplatin chemotherapy and radiotherapy in addition to oral olaparib. Induction chemotherapy (21 day cycle) * Drug: cisplatin 80mg/m2 (day 1) * Drug: 5-FU (fluorouracil) 1000mg/m2/day (day 1-4 continuous infusion) olaparib plus chemoradiotherapy (8 weeks) * Drug: olaparib * Drug: Cisplatin * Radiation

Primary Outcome Measure

Frequency of dose limiting toxicities [ Time Frame: 6 weeks post completion of treatment ]

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