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Anal Canal CarcinomaPhase 2Epitopes-HPV02NCT02402842

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

A Phase 2 study testing Docetaxel, Cisplatin and 5-Fluorouracil in people with Anal Canal Carcinoma, run by Centre Hospitalier Universitaire de Besancon at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anal Canal Carcinoma
What is being tested?
Docetaxel, Cisplatin and 5-Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
16 sitesFrance
Study dates
Sep 2014to 30 Jun 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • University hospital of Besançon

    Besançon, 25000

  • FNLCC center Georges François Leclerc

    Dijon, 21000

  • Oscar Lambret center

    Lille, 59000

  • Jean Mermoz Private Hospital

    Lyon, 69 008

  • Hospital of Belfort-Montbeliard

    Montbéliard, 25200

  • Regional Institute of Cancer

    Montpellier, 34 298

  • Institute of Cancerology of Lorraine

    Nancy, 54 519

  • Antoine Lacassagne Center

    Nice, 06 189

  • Paris Saint-Joseph Hospital Group

    Paris, 75 014

  • Curie Institute

    Paris, 75 248

  • Pitié Salpétrière Hospital

    Paris, 75 651

  • Mutualist Montsouris Institute

    Paris, 75 674

  • European Georges Pompidou Hospital

    Paris, 75 908

  • Saint-Antoine Hospital

    Paris, 75571

  • University Robert Debré Hospital

    Reims, 51 092

  • Paul Strauss Center

    Strasbourg, 67 065

Other trials in France

About this study

Official 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.

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.

Read the detailed description

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.

Being tested
Docetaxel, Cisplatin and 5-Fluorouracil
Keywords
gastrointestinal oncology, immunology, taxane
Medical subject headings
Anal Canal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docetaxel, Cisplatin and 5-FluorouracilDrug

    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.

Study groups in NCT02402842
Study groupRoleWhat they receive
DCF regimenExperimentaldocetaxel 75 mg/m2 day, Cisplatin75 mg/m2 and 5Fluorouracil at 750 mg/m2/day for 5 days
Receives: Drug: Docetaxel, Cisplatin and 5-Fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival rate

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

    Measured: 12 months after initiation of chemotherapy DCF.

Secondary outcomes (6)

  1. Overall survival

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

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

  2. Progression free survival

    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.

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

  3. response rate

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

    Measured: 4 weeks after the end of DCF regimen

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

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

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

  5. quality of life related to health

    EORTC-QLQ-C30 \& time to QoL score deterioration

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

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

    HPV-specific T cell responses measured by ELISPOT assay

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionJun 2018
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02402842
Sponsor's protocol ID
Epitopes-HPV02
Other IDs
2014-001789-81, 2014
Acronym
Epitopes-HPV02
Status last verified
May 2022
First submitted
27 Nov 2014
Last updated
16 May 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim S, Jary M, Mansi L, Benzidane B, Cazorla A, Demarchi M, Nguyen T, Kaliski A, Delabrousse E, Bonnetain F, Letondal P, Bosset JF, Valmary-Degano S, Borg C. DCF (docetaxel, cisplatin and 5-fluorouracil) chemotherapy is a promising treatment for recurrent advanced squamous cell anal carcinoma. Ann Oncol. 2013 Dec;24(12):3045-50. doi: 10.1093/annonc/mdt396. Epub 2013 Oct 10.

    PubMed 24114858

  • Kim S, Meurisse A, Spehner L, Stouvenot M, Francois E, Buecher B, Andre T, Samalin E, Jary M, Nguyen T, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouche O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, de la Fouchardiere C, Boulbair F, Lakkis Z, Klajer E, Jacquin M, Taieb J, Vendrely V, Vernerey D, Borg C. Pooled analysis of 115 patients from updated data of Epitopes-HPV01 and Epitopes-HPV02 studies in first-line advanced anal squamous cell carcinoma. Ther Adv Med Oncol. 2020 Dec 4;12:1758835920975356. doi: 10.1177/1758835920975356. eCollection 2020.

    PubMed 33329760

  • Spehner L, Kim S, Vienot A, Francois E, Buecher B, Adotevi O, Vernerey D, Abdeljaoued S, Meurisse A, Borg C. Anti-Telomerase CD4+ Th1 Immunity and Monocytic-Myeloid-Derived-Suppressor Cells Are Associated with Long-Term Efficacy Achieved by Docetaxel, Cisplatin, and 5-Fluorouracil (DCF) in Advanced Anal Squamous Cell Carcinoma: Translational Study of Epitopes-HPV01 and 02 Trials. Int J Mol Sci. 2020 Sep 17;21(18):6838. doi: 10.3390/ijms21186838.

    PubMed 32957741

  • Stouvenot M, Meurisse A, Saint A, Buecher B, Andre T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouche O, Desrame J, Zoubir M, Smith D, Ghiringhelli F, Parzy A, de la Fouchardiere C, Almotlak H, Vienot A, Jacquin M, Taieb J, Nguyen T, Vernerey D, Borg C, Kim S. Second-line treatment after docetaxel, cisplatin and 5-fluorouracil in metastatic squamous cell carcinomas of the anus. Pooled analysis of prospective Epitopes-HPV01 and Epitopes-HPV02 studies. Eur J Cancer. 2022 Feb;162:138-147. doi: 10.1016/j.ejca.2021.11.019. Epub 2022 Jan 4.

    PubMed 34995900

  • Kim S, Francois E, Andre T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouche O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, De La Fouchardiere C, Smith D, Deberne M, Spehner L, Badet N, Adotevi O, Anota A, Meurisse A, Vernerey D, Taieb J, Vendrely V, Buecher B, Borg C. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2018 Aug;19(8):1094-1106. doi: 10.1016/S1470-2045(18)30321-8. Epub 2018 Jul 2.

    PubMed 30042063

  • Kim S, Jary M, Andre T, Vendrely V, Buecher B, Francois E, Bidard FC, Dumont S, Samalin E, Peiffert D, Pernot S, Baba-Hamed N, El Hajbi F, Bouche O, Desrame J, Parzy A, Zoubir M, Louvet C, Bachet JB, Nguyen T, Abdelghani MB, Smith D, De La Fouchardiere C, Aparicio T, Bennouna J, Gornet JM, Jacquin M, Bonnetain F, Borg C. Docetaxel, Cisplatin, and 5-fluorouracil (DCF) chemotherapy in the treatment of metastatic or unresectable locally recurrent anal squamous cell carcinoma: a phase II study of French interdisciplinary GERCOR and FFCD groups (Epitopes-HPV02 study). BMC Cancer. 2017 Aug 25;17(1):574. doi: 10.1186/s12885-017-3566-0.

    PubMed 28841909

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Cisplatin and 5-Fluorouracil in people with Anal Canal Carcinoma, run by Centre Hospitalier Universitaire de Besancon at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival rate (time frame: 12 months after initiation of chemotherapy DCF.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02402842, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.

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