Protocol: ECOG – EA2176

SCHEMA EA2176

Please Note: Below is partial eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038 for full eligibility requirements. Thank you!

Eligibility:

1. Patient must have inoperable, recurrent, or metastatic disease (tumor resectability should be assessed by a local surgeon or a multidisciplinary team) not amenable to curative therapy.
2. Patient must have histological or cytological confirmation of anal squamous cell carcinoma (includes basaloid and cloacogenic lesions) from the primary tumor or a newly diagnosed recurrent/metastatic lesion.
3. Must be at least 18 years of age.
4. ECOG Performance Status 0-1.
5. Patients must have measurable disease.
6. Patient receiving palliative (limited-field) radiation therapy is allowed, as long as the lesion treated for palliation is not a target lesion.
7. Patients with brain metastasis are eligible if patient is asymptomatic and if treatment ended > 3 months prior to randomization. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression within 4 weeks prior to randomization.
8. Human immunodeficiency virus (HIV)-infected patients on effective Anti-Retroviral Therapy (ART) with undetectable viral load are eligible.
9. Patient must not have had previous use of systemic chemotherapy or other investigational drugs for the treatment of inoperable recurrent or metastatic anal cancer (Previous use of radiotherapy or chemoradiotherapy in this setting is not an exclusion criterion if: 1) non-irradiated target tumor lesions are present at randomization for the purpose of tumor response assessment or 2) in the absence of non-irradiated target tumor lesions, progression of the irradiated tumor
   lesions.
10. Patient must not have had major surgery performed ≤ 28 days prior to randomization.