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Completed

NCT Number: NCT02402842

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

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.

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Key information

Conditions

Anal Canal Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University hospital of Besançon, Besançon, France

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About this study

Epitopes-HPV02 study is a national multicenter open label phase II trial including 66 patients.

Patients will receive 6 cycles of DCF regimen (docetaxel 75 mg/m2 day, CDDP 75 mg/m2 and 5FU at 750 mg/m2/day for 5 days) every 3 weeks or 8 cycles of modified-DCF regimen (docetaxel 40 mg/m2 day, CDDP 40 mg/m2 day and 5-FU at 1200 mg/m2/day for 2 days) every 2 weeks, according to their clinical status.

CT scan will be planned at baseline, after 3 and after 6 cycles of DCF regimen (or after 4 and 8 cycles of modified-DCF regimen) and then every three months until disease progression or death. A Pet-scan will be performed before and after 6 cycles of DCF. Tumor assessment will be carried out according to RECIST V1.1 criteria.

This study is carried out by the University Hospital of Besançon and were approved by the independent Est-II French Committee for Protection of Persons (CPP) and by the French Health Products Safety Agency (ANSM). This study will be conducted in 17 clinical centers in France.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel, cisplatin and 5-fluorouracil

Drug

Patients will receive 6 cycles of DCF regimen (docetaxel 75 mg/m2 day, cisplatin 75 mg/m2 and 5 Fluorouracil at 750 mg/m2/day for 5 days) every 3 weeks or 8 cycles of modified-DCF regimen (docetaxel 40 mg/m2 day, cisplatin 40 mg/m2 day and 5-Fluorouracil at 1200 mg/m2/day for 2 days) every 2 weeks, according to their clinical status.

Primary outcomes

  1. Progression-free survival rate

    Time frame: 12 months after initiation of chemotherapy DCF.

    Progression-free survival observed = the number of patients alive without progression at 12 months.

Secondary outcomes

  1. Overall survival

    Time frame: date of death from any cause (within 3 years after the initiation of the treatment)

    time between the date of initiation of treatment and the date of death from any cause.

  2. Progression free survival

    Time frame: date of first progression of the disease (within 3 years after the initiation of the treatment)

    time interval between the date of initiation of treatment and the date of first progression (local, remote [extent of the disease by RECIST v1.1] second cancer) or death from any cause.

  3. response rate

    Time frame: 4 weeks after the end of DCF regimen

    response rate will be evaluated using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 by CT-scan

  4. Tolerance of the DCF regimen ( Common Terminology Criteria for Adverse Events version 4.03)

    Time frame: from the initiation of DCF regimen to 4 weeks after the end of DCF regimen

    description of toxicities and adverse events according to Common Terminology Criteria for Adverse Events version 4.03

  5. quality of life related to health

    Time frame: from the inclusion to patient death or for maximum 3 years after end of treatment

    EORTC-QLQ-C30 & time to QoL score deterioration

  6. HPV-specific T cell responses measured by ELISPOT assay before and after DCF treatment

    Time frame: at baseline (inclusion) and 4 weeks after the end of DCF regimen

    HPV-specific T cell responses measured by ELISPOT assay

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Assessment of the Clinical Value of a Docetaxel, Cisplatin and 5-fluorouracil (DCF) Strategy Adapted to Patients for the Management of Metastatic or Locally Advanced Anal Resistant Radiochemotherapy Squamous Cell Anal Carcinoma.

Acronym: Epitopes-HPV02

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
Mar 30, 2015
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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