• InterAACT
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Trial Status

Completed

Cancer Type

Anal Cancer

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.

Purpose of the Study

The aim of InterAACT is to compare two different chemotherapy regimens for the treatment of inoperable locally advanced or metastatic anal cancer to demonstrate which is more effective and less toxic for patients with this disease.

Anal cancer is a rare cancer, with approximately 150 cases being diagnosed in Australia every year. However, the number of anal cancer cases has been steadily growing and has doubled in the last 20 years.  InterAACT is an international, multicentre, open label, randomised, phase II trial that aims to establish which chemotherapy regime is more active in patients with inoperable locally advanced or metastatic anal cancer. This is the first time that a formal comparison of two chemotherapy regimens has been performed.  The results have the potential to establish a new standard of care for this group of patients.

Key Eligibility Criteria

Inclusion Criteria

  1. Inoperable, locally recurrent or metastatic disease
  2. Age greater than or equal to 18 years.
  3. Adequate cardiac and respiratory function;
  4. Fertile men and women must agree to take adequate contraceptive precautions during, and for at least six months after therapy.
  5. Life expectancy of at least 3 months.

Exclusion Criteria

  1. Newly diagnosed locally advanced tumour which requires upfront systemic chemotherapy
  2. Locally recurrent tumour
  3. Tumour relapse/progression within 6 months
  4. Major surgery performed less than 28 days from treatment start.
  5. Palliative radiotherapy completed less than or equal to 7 days from treatment start.
  6. Clinically significant cardiac disease
  7. History of interstitial lung disease
  8. HIV positive patients who are not on HAART
  9. Other malignancy within the last 5 years
  10. Pregnant or lactating females.

More Information

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

Principal Investigator

Dr Amitesh Roy

Funding

GI Cancer Institute

Participating Centres

New South Wales
Prince of Wales Hospital
Queensland
Princess Alexandra Hospital
South Australia
Flinders Medical Centre
Tasmania
Royal Hobart Hospital
Victoria
Austin Health

Trial Status

Completed

Cancer Type

Anal Cancer

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.

Participating Centres

New South Wales
Prince of Wales Hospital
Queensland
Princess Alexandra Hospital
South Australia
Flinders Medical Centre
Tasmania
Royal Hobart Hospital
Victoria
Austin Health

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