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Open-label, Randomized, Controlled Phase I/II Study of Cilengitide to Evaluate the Safety and Efficacy of the Combination of Different Regimens of Cilengitide Added to Cisplatin, 5-FU, and Cetuximab in Subjects With Recurrent/Metastatic Squamous Cell Cancer of the Head and Neck


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Squamous Cell Cancer

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Trial Information

Open-label, Randomized, Controlled Phase I/II Study of Cilengitide to Evaluate the Safety and Efficacy of the Combination of Different Regimens of Cilengitide Added to Cisplatin, 5-FU, and Cetuximab in Subjects With Recurrent/Metastatic Squamous Cell Cancer of the Head and Neck


Inclusion Criteria:



- Histologically or cytologically confirmed diagnosis of SCCHN

- At least one measurable lesion either by computerized tomography (CT) scan or
magnetic resonance imaging (MRI)

- Karnofsky performance status (KPS) of greater than or equal to 70 or eastern
cooperative oncology group performance status (ECOG PS) of 0-1 at trial entry

Exclusion Criteria:

- Prior systemic chemotherapy, except if given as part of a multimodal treatment for
locally advanced disease, which was completed more than 6 months prior to trial entry

- Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before
trial entry

- Nasopharyngeal Carcinoma

- Documented or symptomatic brain or leptomeningeal metastasis

- Previous treatment with epidermal growth factor receptor (EGFR) targeting therapy or
signal transduction inhibitors

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) time: Investigator read

Outcome Description:

The PFS is defined as the duration from randomization until radiological progression (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment. Investigator read is the assessment of all imaging by the treating physician at the local trial site.

Outcome Time Frame:

Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 01 October 2008, until cut-off date (03 September 2011)

Safety Issue:

No

Principal Investigator

Jan Vermorken, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Antwerp

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

EMR 200052-013

NCT ID:

NCT00705016

Start Date:

October 2008

Completion Date:

December 2012

Related Keywords:

  • Squamous Cell Cancer
  • Randomized treatment
  • open-label
  • controlled
  • recurrent
  • metastatic
  • SCCHN
  • suitable
  • for local therapy
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

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