Study Stopped
Study stopped due to issues surrounding development and formulation of olaparib
Phase I Study of Olaparib With Cisplatin Based Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck
ORCA
A Phase I/II Study of Olaparib in Addition to Cisplatin Based Concurrent Chemoradiotherapy for Patients With High Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2011
CompletedFirst Posted
Study publicly available on registry
December 13, 2011
CompletedMay 30, 2012
May 1, 2012
December 9, 2011
May 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of dose limiting toxicities
6 weeks post completion of treatment
Secondary Outcomes (2)
Complete response rate
12 weeks post completion of treatment
Time to loco-regional progression
2 years post completion of treatment
Study Arms (1)
single arm
EXPERIMENTALAll 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
Interventions
Given twice daily. Exposure will escalate by daily dose and duration.
Total dose will be 70Gy in 35 fractions over 7 weeks.
Eligibility Criteria
You may qualify if:
- Histologically confirmed high risk, locally advanced HNSCC patients (TNM staging: T-any N2/3 M0, bulky T3 or T4 N-any M0) who would normally be offered cisplatin-based radical chemoradiotherapy
- Estimated life expectancy of at least 12 weeks
- WHO performance status of 0 or 1
- Aged ≥18 years of age
- Adequate major organ function
- Willing to use contraception for the duration of the trial treatment and for six months after completion of treatment
- Able to give informed consent
- Willing and able to comply with the protocol for the duration of the study
You may not qualify if:
- Head \& neck cancers of the following types:
- Nasopharyngeal and paranasal sinus tumours,
- Oral squamous cell carcinomas (tumours of the oral cavity),
- Human Papilloma Virus positive oropharyngeal tumours (tonsillar and tongue base tumours)
- Confirmed distant metastatic disease
- Previous chemotherapy or radiotherapy for the treatment of HNSCC tumour
- Previous therapy with a PARP inhibitor
- Pre-existing gastrointestinal disorders that may interfere with the delivery or absorption of olaparib
- Grade 3 or 4 peripheral neuropathy
- Significant hearing difficulties or tinnitus (deaf patients can be included)
- The current use of drugs which are known to inhibit or induce CYP3A4
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- AstraZenecacollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin D Forster, MBBS
University College London Hospitals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2011
First Posted
December 13, 2011
Last Updated
May 30, 2012
Record last verified: 2012-05