CompletedPhase 2

Clinical and Biological Interest of Taxanes in Advanced Squamous Cell Anal Carcinoma

France70 participantsStarted 2014-09

Plain-language summary

Squamous cell carcinoma of the anal canal (SCCA) is a rare disease and mostly diagnosed at an early stage. After standard concurrent chemoradiation (CRT) with mitomycin (MMC) and 5-fluorouracil (5FU), the disease will recur in 20% of patients. After treatment failure (including salvage surgery), cisplatin-5FU combination is the standard option but complete response is a rare event and the prognosis remains poor with most patients' death occurring in the first 12 months. Decision making for physicians in this setting is only based on retrospective studies or small phase II clinical trials including less than 20 patients. Hence, no efficient standard of care is currently available for relapsing SCCA patients who are currently treated with a palliative intent. Between 2007 and 2013, 8 consecutive patients with advanced recurrent SCCA after CRT were treated with DCF regimen (docetaxel, cisplatin and 5-fluorouracil) in the Regional Cancer Institute of Franche Comté. After a median follow-up of 41 months, 4 patients (50%) achieved a complete response. Three patients underwent surgery of all involved metastatic sites. A pathological complete response was observed for all of them including in metastases occurring in irradiated fields, suggesting that taxane-based chemotherapy might be an effective strategy to circumvent resistance to radiotherapy (a preliminary cohort of 8 patients was published (Kim S et al Annals of oncology 2013). Furthermore, all complete responders were HPV 16, and high levels of specific T cell responses against Human Papillomavirus (HPV) HPV16-derived E6/E7 and telomerase were detected in 50% of complete responders suggesting the potential restoration of cancer immunosurveillance by this regimen. Then, the Epitopes-HPV02 multicenter phase II study will aim to confirm the new role of taxane-based chemotherapy in SCCA patients.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Age ≥ 18 years * Performance status ECOG-WHO ≤ 1 * histologically proved and unresectable locally advanced or metastatic squamous cell anal carcinoma * patient eligible to DCF regimen * signed written informed consent Exclusion Criteria: * known hypersensitivity or contraindication to any of the study drugs (docetaxel, cisplatin, 5-fluorouracil). * previous chemotherapy for metastatic disease * previous chemotherapy by paclitaxel, docetaxel or navelbine * previous chemotherapy by cisplatin, except of concomitant radiotherapy * SIDA * clinically significant cardiac disease * other malignancy within the last 3 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. * simultaneous participation in another clinical study * pregnancy, breast-feeding or absence of adequate contraception for fertile patients * patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study. * patient under guardianship, curator or under the protection of justice.

What they're measuring

Progression-free survival rate

Timeframe: 12 months after initiation of chemotherapy DCF.

Trial details

NCT IDNCT02402842

SponsorCentre Hospitalier Universitaire de Besancon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06