Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18+
Clinical summary
Summary
The purpose of the study is to compare two different chemotherapy regimens for the treatment of inoperable, locally recurrent, or metastatic anal cancer to demonstrate which is more effective and less toxic for patients with this disease. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with inoperable, locally recurrent or metastatic anal cancer. Study details: Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive chemotherapy treatment with cisplatin and 5-FU for 8 x 3 week cycles (about 24 weeks in total) – this is the most frequently prescribed chemotherapy for this condition. Participants in the other group will receive chemotherapy with carboplatin and paclitaxel in 6 x 4 week cycles (24 weeks in total). Both groups will receive their chemotherapy intravenously, i.e. given into a vein through a drip. All participants will be followed for up to 3 years post treatment in order to evaluate treatment response, toxicity and quality of life. This is the first time that a formal comparison of these chemotherapies has been performed.
Conditions
This trial is treating people with Anal Cancer
Eligibility
Inclusion
- Histologically or cytologically verified, uni-dimensionally measurable, inoperable, locally recurrent or metastatic squamous cell carcinoma of the anus.
- Age ≥18 years.
- ECOG Performance status ≤2.
- Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1.
- Previous definitive chemoradiotherapy is permitted for early stage squamous cell carcinoma of the anus.
- HIV+ patients will be considered eligible with a CD4 count of ≥200.
- Adequate cardiac and respiratory function; absolute neutrophil count (ANC) ≥1.5x10^9/l; white blood cell (WBC) count ≥3x10^9/l; platelets >100x10^9/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.
- Fertile men and women must agree to take adequate contraceptive precautions during, and for at least six months after therapy.
- Life expectancy of at least 3 months.
Exclusion
- Tumours of adenocarcinoma, melanoma, small cell and basal cell histology are excluded.
- Previous chemotherapy, radiotherapy or other investigational drug for surgically unresectable locally recurrent or advanced squamous cell carcinoma of the anus
- Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study.
- Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease.
- Surgery or palliative radiotherapy within 28 days of randomisation.
- 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.
- History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan.
- Lack of physical integrity of the gastro-intestinal tract, malabsorption syndrome (naso-gastric or jejunostomy feeding tube is permitted).
- Acute hepatitis C and/or chronic active hepatitis B infection.
- Serious active infection requiring i.v. antibiotics at enrolment.
- 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.
- Other clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this trial.
- Known hypersensitivity to any of the study drugs or excipients.
- Known peripheral neuropathy ≥ grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible).
- Pre-existing hearing impairment.
- Patients planning for a live vaccine.
- Pregnant or lactating females.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR, ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Australasian Gastro-Intestinal Trials Group (AGITG)
Scientific Title
An International Multicentre Open Label Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin Plus 5 FU vs Carboplatin Plus Weekly Paclitaxel in Patients With Inoperable Locally Recurrent or Metastatic Disease
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