Clinical Trials Logo
  1. Home
  2. Carcinoma, Squamous Cell
  3. NCT01491139

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

Carcinoma, Squamous Cell Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

This is a dose escalating Phase I/II trial evaluating the safety and tolerability of the addition of olaparib to CRT in high risk locally advanced human papillomavirus (HPV) negative Squamous Cell Carcinoma of the Head and Neck (HNSCC). A fixed dose of weekly cisplatin and intensity-modulated radiation therapy (IMRT) will be used, with doses of olaparib escalating for consecutive days and both dose level and duration will be increased through each cohort.

This Phase I trial will assess how olaparib, a poly ADP ribose polymerase (PARP) inhibitor is tolerated when added to standard chemoradiotherapy treatment.

Patients will be recruited from sites in the UK only.

A placebo controlled, randomised Phase II trial will follow once the recommended dose and schedule of olaparib has been established. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01491139
Study type Interventional
Source University College, London
Contact
Status Withdrawn
Phase Phase 1
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT02743832 - A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma. N/A
Active, not recruiting NCT02229656 - Olaparib and Radiotherapy in Head and Neck Cancer Phase 1
Completed NCT00389727 - Simultaneous Integrated Boost (SIB)- IMRT Phase 2
Recruiting NCT02328391 - STUDY OBSERVATIONAL OF ERLOTINIB AS SECOND LINE TREATMENT IN PATIENTS WITH SQUAMOUS NSCLC AND EGFR NATIVE N/A
Completed NCT00534950 - Randomized Multicenter Study of 5 vs 6 Weekly Fraction of RT in the Treatment of SCC of the Head and Neck N/A
Completed NCT00875381 - Analysis of Melanocytes (Pigment Cells) in Sun-Exposed Skin N/A
Terminated NCT00073450 - Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530) Phase 2
Terminated NCT01441128 - -02341066 and PF-00299804 for Advanced Non-Small Cell Lung Cancer Phase 1
Recruiting NCT05970497 - A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors Phase 1
Completed NCT01362127 - Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia Phase 2
Completed NCT00240682 - Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR Phase 2
Terminated NCT02254044 - Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus Phase 1
Active, not recruiting NCT00829192 - Phase II AK Study in Organ Transplant Patients Phase 2
Completed NCT00539630 - TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN Phase 3
Completed NCT00313027 - Cervical Nodal Mets in Squamous Cell Carcinoma of H&N - MRI, FDG-PET, & Histopathologic Correlation N/A
Recruiting NCT04564989 - Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
Not yet recruiting NCT06094829 - Tobacco and Alcohol Influence on Oncogenic Drivers and Somatic Evolution in the Oral Mucosa
Recruiting NCT04481256 - TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY N/A
Active, not recruiting NCT02664935 - National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer Phase 2
Terminated NCT02438995 - Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck Phase 1