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Carcinoma of Anal CanalPhase 2NCT01843452

Phase II Study of Concomitant Intensity-modulated Radiotherapy Combined to Capecitabine, Mitomycin and Panitumumab in Patients With Stage II-IIIB Squamous-cell Carcinoma of the Anal Canal

A Phase 2 study testing RADIOTHERAPY, PANITUMUMAB and MITOMYCIN in people with Carcinoma of Anal Canal, run by Centre Hospitalier Universitaire Vaudois at 4 sites in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

There is increasing evidence of a role of EGFR, treatment with EGFR-inhibitors in anal cancer and synergies of EGFR-inhibitors with radiotherapy. Addition of the human anti-EGFR antibody Panitumumab to chemoradiotherapy seems therefore solidly justified. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma of Anal Canal
What is being tested?
RADIOTHERAPY, PANITUMUMAB and MITOMYCIN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
4 sitesSwitzerland
Study dates
Dec 2012to May 2016
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

  • Histologically/pathologically confirmed squamous-cell carcinoma of the anal canal
  • Stage II-IIIB (T2-4, N any, M0) disease
  • Previously untreated disease
  • Age ≥ 18 years at time of consent
  • Life expectancy of at least 2 years
  • ECOG performance status (PS) of 0 to 1
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  • Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements to be conducted within 14 days prior to registration.
  • Hemoglobin ≥ 90 g/l without transfusion requirement in the prior 4 weeks
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L
  • Platelet count ≥ 100 x 109/L
  • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 x ULN
  • Alkaline phosphatase < 4 x ULN
  • PT/PTT < 1.5 x ULN (patients who receive anticoagulation treatment with an agent such as warfarin or heparin will be allowed to participate; for patients on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at predose, as defined by the local standard of care.
  • Serum creatinine clearance ≤ 1.5 x ULN (≥ 60 ml/min calculated using the Cockcroft-Gault formula)
  • Patients with stable HIV infection (i.e. undetectable viral load over the past 6 months while on HIV treatment and with CD4 count > 200 /ml) can be included.
  • Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations

Who cannot join

  • Prior treatment with capecitabine or mitomycin
  • Prior or concurrent chemotherapy, or any antitumoral hormonal therapy
  • Prior treatment with panitumumab or other EGFR inhibitors
  • Prior biologic therapy or immunotherapy, e.g. anti-TNF treatment etc.
  • Less than 24 hours since prior granulocyte colony-stimulating factors
  • Any other concurrent anticancer therapy, including experimental medications
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  • Receipt of any investigational agent within 4 weeks of study registration
  • Concurrent alternative medicine, vitamin supplements unless approved by the investigator
  • Prior radiation therapy to the pelvis
  • Prior surgery for anal canal cancer except biopsy
  • Evidence of metastatic disease
  • Prior or concurrent malignancy other than the study disease unless treated with curative intent and with no evidence of disease
  • Any of the following within 6 months prior to study drug administration: severe/ unstable angina (symptoms at rest), new onset angina (began within the last 3 months) or myocardial infarction, congestive heart failure, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Known active Hepatitis B or C
  • Active clinically serious infection > NCI-CTCAE v4.0 grade 3
  • Known or suspected allergy to panitumumab or any agent given in the course of this trial
  • Any condition that impairs patient's ability to swallow whole pills
  • Symptomatic pulmonary fibrosis
  • History of collagen vascular disease
  • Other severe, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate contraception during the course of the trial and three months after the completion of trial
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Trial locations and contacts

4 sites in 1 country.

Switzerland4 sites

  • Inselspital

    Bern, 3010

  • Hôpitaux Universitaires de Genève (HUG)

    Geneva

  • Centre Hospitalier Universitaire Vaudois

    Lausanne

  • Hôpital du Valais (RSV)

    Sion

Other trials in Switzerland

About this study

There is increasing evidence of a role of EGFR, treatment with EGFR-inhibitors in anal cancer and synergies of EGFR-inhibitors with radiotherapy. Addition of the human anti-EGFR antibody Panitumumab to chemoradiotherapy seems therefore solidly justified. This trial investigates concurrent panitumumab/capecitabine/mitomycin concurrent to IMRT-radiotherapy. Treatment components used in this study have been selected on scientific rationale. The trial regimen should be feasible with acceptable toxicity and outcome similar to historic series.

Read the detailed description

OBJECTIVES:

Primary:

-To assess efficacy of treatment regimen composed of capecitabine, mitomycin, panitumumab, and radiotherapy in terms of locoregional control rate in patients with stage II-IIIB squamous-cell carcinoma of the anal canal.

Secondary:

  • To further assess efficacy of this regimen based on complete response (CR) rate, colostomy-free survival, functional colostomy-free survival, overall survival (OS), and progression-free survival (PFS).
  • To assess the tolerability and safety profile of this regimen.
  • To assess the role of PET for staging and outcome prediction (for those patients who had PET following local standards).
Being tested
RADIOTHERAPY, PANITUMUMAB, MITOMYCIN, CAPECITABINE
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.

  • RADIOTHERAPYRadiation

    External beam radiotherapy (daily fraction dose 1.8Gy) on Monday through Friday starting on study day 1.

    • Days 1-28, dose of 36 Gy in 1.8 Gy/fraction (20 fractions) to the clinical target volume 1 (CTV1) including the primary tumor and involved lymph nodes and areas at risk for metastatic spread (which includes gross tumour volumes (GTV) and a 1-cm expansion, mesorectal space, inguinal, femoral, external iliac, internal iliac, and common iliac vessels).
    • Days 29-45, a boost dose of 23.4 Gy in 1.8 Gy/fraction (13 fractions) to the GTV.

  • PANITUMUMABBiological

    6 mg/kg IV administered over 60 min infusion on days 1,15 and 29.

  • MITOMYCINDrug

    10 mg/m2 IV administered over 15 min infusion on days 1 and 29.

  • CAPECITABINEDrug

    825mg/m2 orally twice daily on study days 1 through 45.

Study groups in NCT01843452
Study groupRoleWhat they receive
Capecitabine, mitomycin, panitumumab and radiotherapyExperimentalRADIOTHERAPY: daily fraction dose of 1.8Gy , 5 days a week between day 1 and 45 Intensity modulated radiotherapy (IMRT), using a linac based facility or helical tomotherapy, is obligatory. The first treatment sequence consists of a total dose of 36 Gy in 20 daily fractions of 1.8 Gy on five days a week. The second treatment sequence consists of a total dose of 23.4 Gy in 13 daily fractions of 1.8 Gy on five days a week. PANITUMUMAB: 6 mg/kg IV over 60 min infusion on days 1, 15 and 29 MITOMYCIN: 10 mg/m2 IV over 15 min infusion on days 1 and 29 CAPECITABINE: 825 mg/m2 oral twice daily on days 1 to 45
Receives: Radiation: RADIOTHERAPY; Biological: PANITUMUMAB; Drug: MITOMYCIN; Drug: CAPECITABINE

What is being measured

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

  1. Efficacy

    Measured: 2-year locoregional control in patients, which is defined as the absence of locoregional recurrence 2 years after treatment start.

Secondary outcomes (7)

  1. Complete response (CR) rate

    Tumor assessment will be done by the investigator according to the RECIST 1.1. criteria.

    Measured: 5 years

  2. Colostomy-free survival

    2-year colostomy-free survival (patients without colostomy two-years after treatment start).

    Measured: 2 and 5 years

  3. Functional colostomy-free survival

    2-year functional colostomy-free survival (patients without colostomy and without stool incontinence or other sphincter symptoms interfering with activities of daily life two years after treatment start, which correspond to grade 3 toxicity according to common toxicity criteria National Cancer Institute-Common Toxicity Criteria for Adverse Event (NCI-CTCAE) version 4.0.

    Measured: 2 and 5 years

  4. Overall survival (OS)

    2-year overall survival (proportion of patients alive two years after treatment start) and median overall survival (median of the interval (days) between treatment start and death for any cause).

    Measured: 2 and 5 years

  5. Progression-free survival (PFS)

    2-year PFS (proportion of patients progression-free two years after treatment start) and median PFS according to the RECIST 1.1 criteria. PFS is defined as the interval (days) between registration and the date of progression (based on the actual tumor assessment date), or death for any cause, whichever comes first. The death of a patient without a reported progression will be considered as an event on the date of death. Patients who have neither progressed nor died will be censored on the date of last evaluable tumor assessment. Patients who had no post-baseline assessments and did not have an event will be censored at the time of registration.

    Measured: 2 and 5 years

  6. Tolerability and safety profile of this regimen.

    Toxicities will be assessed according to the NCI-CTCAE (version 4.0).

    Measured: Early (6 weeks after treatment) and late (up to 2 and 5 years after treatment).

  7. Role of PET for staging and outcome prediction.

    Predictive value of PET for PFS. Comparison of PET for determination of complete response with radiologic response and clinical response.

    Measured: 5 years

Timeline

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

  1. First posted30 Apr 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionMay 2016
  4. Study completionMay 2016

Why it stopped: Poor recruitment

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
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01843452
Sponsor's protocol ID
CHUV 20080214
Status last verified
May 2016
First submitted
26 Apr 2013
Last updated
19 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RADIOTHERAPY, PANITUMUMAB and MITOMYCIN in people with Carcinoma of Anal Canal, run by Centre Hospitalier Universitaire Vaudois at 4 sites in Switzerland.

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 17 inclusion and 22 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: stopped early, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland. 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 was stopped early (reason given: Poor recruitment). Results are not available in the source record.

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?

Efficacy (time frame: 2-year locoregional control in patients, which is defined as the absence of locoregional recurrence 2 years after treatment start.). 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 NCT01843452.

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 19 May 2016.

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