InterAACT

Protocol Title

An International Multicentre Open Label Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin plus 5-fluorouracil versus Carboplatin plus Weekly Paclitaxel in Patients with Inoperable Locally Recurrent or Metastatic Disease.

Conference Presentation Reference

Sclafani F, Adams RA, Eng C, Benson AB, Glynne-Jones R, Sebag-Montefiore D, Arnold D, Roy AC, Guren MG, Segelov E, Seymour MT, Bryant A, Peckitt C, Cunningham D, Bridgewater JA, Welch J, O’Dwyer PJ, Dupont E, McConnell A, Rao S. InterAACT: An international multicenter open label randomized phase II advanced anal cancer trial comparing cisplatin plus 5-fluorouracil versus carboplatin plus weekly paclitaxel in patients with inoperable locally recurrent or metastatic disease. American Society of Clinical Oncology 50th Annual Meeting; 30 May–3 Jun 2014; Chicago.

Aim

The aim of the study is to compare two different chemotherapy regimens for the first-line treatment of inoperable, locally recurrent, or metastatic squamous cell carcinoma of anus to determine the best overall response rate and evaluate toxicity and quality of life in order to demonstrate which regimen is more active and less toxic for patients with this disease.

Background

There has yet to be an established standard chemotherapy regimen for patients with inoperable locally advanced or metastatic anal cancer. Currently, the most common chemotherapy treatment is a combination of two drugs called Cisplatin and 5-Flurouracil. However, a formal comparison of this combination with other chemotherapies – such as Carboplatin and Paclitaxel (potentially more effective and/or less toxic) has never been performed. There is an unmet need to compare regimens to help establish which combination regimen can be established as the most effective chemotherapy treatment. The results could also be used to inform design for future phase III clinical trials in this tumour.

InterAACT is an international, multicentre trial that aims to establish which chemotherapy regime is more active and less toxic for patients with inoperable locally advanced or metastatic anal cancer. This is the first time that a formal comparison of these chemotherapies has been performed.  The results have the potential to establish a new standard of care for this group of patients. The study also aims to acquire important information on the biology of anal cancer by incorporating translational research as part of its overall research aim.

Clinical Trial Design

InterAACT is a randomised, multicentre Phase II trial.

Eligible participants will be randomly allocated to one of the two groups. One group (approximately half of the participants) will be the control arm of the trial and receive chemotherapy with Cisplatin and 5-Flurouracil, which will be administered intravenously. This is the most frequently prescribed chemotherapy for this condition. The control treatment will occur once in every 3-week cycle. Participants will receive 8 cycles or total of 24 weeks of treatment.

Patients in the other group will be in the experimental arm of the trial. The experimental treatment will consist of chemotherapy with Carboplatin and Paclitaxel. Carboplatin will be given once every 4 weeks and Paclitaxel is given weekly, 3 out of 4 weeks every 4 weeks. Both Carboplatin and Paclitaxel will each be administered intravenously. This will continue for 24 weeks in total.

Recruitment is expected to take about 3 years. Post-treatment, all participants will be followed up to evaluate treatment response, toxicity and quality of life.

Key Eligibility Criteria

Please note that the information below contains only the most important inclusion and exclusion criteria and is not a comprehensive list.

Key inclusion criteria:

• Adults (18 years or over) with inoperable, locally recurrent or metastatic anal cancer
• Histological or cytological confirmation of epidermoid anal carcinoma (includes squamous, basaloid, and cloacogenic lesions)
• HIV positive patients will be considered eligible if they are on HAART and have a CD4 count of greater than or equal to 200/microliter
• Adequate cardiac and respiratory function
• Willing to follow all study requirements, including treatment, timing and/or nature of required assessments and follow-up.

Key exclusion criteria:

• Tumours of adenocarcinoma, melanoma, small cell and basal cell histology are excluded
• Newly diagnosed locally advanced tumour, which requires upfront systemic chemotherapy but is still amenable to curative treatment
• Previous use of systemic chemotherapy or other investigational drugs for the treatment of inoperable locally recurrent or metastatic tumours
• Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study
• Major surgery performed less than 28 days from treatment start
• HIV positive patients who are not on HAART or have a CD4 count of less than 200/microlitre in the presence of detectable plasma viral load according to the local assay.
• Known history of active hepatitis B or hepatitis C infection.
• History of lung disease.

Visit ANZTCR for more detailed information on inclusion/exclusion criteria and eligibility.

Contact Email

Principal Investigator

Dr Amitesh Roy (Flinders Centre for Innovation in Cancer, Bedford Park SA).

More Information

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here.

Funding

GI Cancer Institute