PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/19/2018 |
| Start Date: | January 1, 2007 |
| End Date: | January 1, 2014 |
A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…
This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation
clinical trial of docetaxel and cisplatin combination chemotherapy with and without
panitumumab in the first-line treatment of subjects with metastatic or recurrent head and
neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail
the chemotherapy only arm. This study will be conducted in the United States. Approximately
150 subjects with histologically or cytologically confirmed metastatic and/or recurrent
SCCHN.
clinical trial of docetaxel and cisplatin combination chemotherapy with and without
panitumumab in the first-line treatment of subjects with metastatic or recurrent head and
neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail
the chemotherapy only arm. This study will be conducted in the United States. Approximately
150 subjects with histologically or cytologically confirmed metastatic and/or recurrent
SCCHN.
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic and/or recurrent Squamous Cell
Carcinoma of Head and Neck (SCCHN) determined to be incurable by surgery and/or
radiation therapy.
- Measurable disease by CT scan
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Age: 18 years or older
- Adequate hematologic, renal, metabolic, hepatic & thyroid function
Exclusion Criteria:
- Prior systemic treatment for metastatic and/or recurrent SCCHN
- CNS metastases, or nasopharyngeal carcinoma
- History of interstitial lung disease
- History of another primary cancer
- Any co-morbid disease that would increase risk of toxicity
- Active infection requiring systemic treatment
- Prior anti-Epidermal Growth Factor receptor (anti-EGFr) antibody therapy
We found this trial at
71
sites
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