A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer (NCT01087970) | Clinical Trial Compass
CompletedPhase 2
A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer
United States69 participantsStarted 2010-08
Plain-language summary
The purpose of this study is to look for an improvement in progression free survival with the combination of pemetrexed, carboplatin (or cisplatin) and cetuximab in participants with recurrent or metastatic squamous cell carcinoma of the head and neck.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologic or cytologic diagnosis of squamous cell head and neck cancer (HNC)
* Recurrent disease (locally advanced or metastatic) that is not amenable to local therapy, (i) with at least 6 months since completion of systemic therapy (chemotherapy or biological anticancer therapy), and (ii) with no more than 1 prior multimodal therapy (such as concurrent chemoradiation with or without sequential chemotherapy) for locally advanced HNC tumor, and (iii) with no prior systemic therapy (chemotherapy or biological anticancer therapy) for metastatic disease; OR
* Newly diagnosed distant metastatic disease (Stage IVc)
* Prior therapies:
* Radiation therapy must be completed at least 4 weeks before study enrollment. For palliative therapy, prior radiation therapy allowed \<25% of the bone marrow and prior radiation to the whole pelvis is not allowed. Participants must have recovered from the acute toxic effects of the treatment prior to study enrollment.
* Surgery (excluding prior diagnostic biopsy) must be completed at least 4 weeks before study enrollment. Participants must have fully recovered from any acute effects of surgery prior to study enrollment.
* An estimated life expectancy of at least 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Biological tissue available for biomarker analysis on tumor tissue.
* Disease status must be measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Th…
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: From enrollment to measured progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment, and then every 6 weeks during follow-up)