An international multicentre clinical trial comparing two chemotherapy regimens in patients with advanced anal cancer

• Conditions: Inoperable, locally recurrent or metastatic squamous cell carcinoma of the anus; MedDRA version: 18.0Level: LLTClassification code 10041815Term: Sq cell Ca anusSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001949-13-GB
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-20
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.Histologically or cytologically verified, uni-dimensionally measurable, inoperable, locally recurrent or metastatic squamous cell carcinoma of the anus.
2.Age =18 years.
3.ECOG PS =2.
4.Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1.
5.Previous definitive chemo-radiation is permitted for early stage squamous cell carcinoma of the anus.
6.HIV+ patients will be considered eligible with a CD4 count of =200.
7.Adequate cardiac and respiratory function; absolute neutrophil count (ANC) =1.5x109/l; white blood cell (WBC) count =3x109/l; platelets =100x109/l; haemoglobin (Hb) =9g/dl; creatinine clearance =50ml/minute; serum bilirubin =1.5x upper limit of normal (ULN); alanine transaminase (ALT)/aspartate transaminase (AST) =2.5x ULN; alkaline phosphatase (ALP) =3x ULN.
8.Life expectancy of at least 3 months.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Tumours of adenocarcinoma, melanoma, small cell and basal cell histology are
excluded.
2.Previous chemotherapy, radiotherapy or other investigational drug for surgically unresectable locally recurrent or advanced squamous cell carcinoma of the anus.
3.Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study.
4.Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease.
5.Surgery or palliative radiotherapy within 28 days of randomisation.
6.Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, or myocardial infarction within the last 6 months). Any history of clinically significant cardiac failure.
7.History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan.
8.Lack of physical integrity of the gastro-intestinal tract, malabsorption syndrome (naso-gastric or jejunostomy feeding tube is permitted).
9.Acute hepatitis C and/or chronic active hepatitis B infection.
10.Serious active infection requiring i.v. antibiotics at enrolment.
11.Other malignancy within the last 5 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.
12.Other clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this trial.
13.Known hypersensitivity to any of the study drugs or excipients.
14.Pregnant or lactating females.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified