International Multicentre Study in Advanced Anal Cancer Comparing Cisplatin... | Recruiting
International Multicentre Study in ... | Recruiting
International Multicentre Study in Advanced Anal Cancer Comparing Cisplatin Plus 5 FU vs Carboplatin Plus Weekly Paclitaxel
InterAACT

Location not identified by Google services

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Medical Conditions
  • Squamous Cell Carcinoma of the Anus
Primary Contact Details
Sheela Rao, MD, FRCP
1380 +44 (0) 0208 642 6011
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02051868
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
Anal cancer is a relatively uncommon disease and there is currently no standard chemotherapy treatment for patients with inoperable locally recurrent or metastatic disease. The aim of this phase II study is compare two well known and largely used chemotherapy regimens - Cisplatin plus 5-fluorouracil vs Carboplatin plus Paclitaxel. The result of this study will set a standard of care for this disease and provide useful information for future Phase III trials.
Research Details
  • Study design: This is an international, multicentre, open label, randomised phase II trial. Patients will be randomised to receive either cisplatin plus 5-FU or carboplatin plus weekly paclitaxel. Region (Europe, North America, South America & Australia), (Eastern Cooperative Oncology Group- ECOG) ECOG performance status (PS) (0-1 vs. 2), HIV status (positive vs. negative) and extent of disease (locally recurrent vs. metastatic) will be used as stratification factors. Overall response rate is the primary endpoint.

    Indication: First line treatment of patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anus.

    Length of study: Recruitment should be completed within 3 years. The estimated recruitment rate is between 4-6 patients per month once it is established at multiple centres.

    Primary Objective: To evaluate best overall response rate by 24 weeks post treatment in the cisplatin plus 5-fluorouracil arm versus the carboplatin plus weekly paclitaxel arm

    Secondary Objectives: To evaluate: - Progression-free survival - Overall survival - Disease control rate (stable disease or better) at 12 and 24 weeks - Best overall response of metastatic lesions - Toxicity (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 4) - Quality of Life (using EORTC QLQ-C30 version 3 and EQ-5D-5L questionnaires).

    To assess: The feasibility of conducting a multicentre international study on squamous cell carcinoma of the anus and recruit within a reasonable time frame.

    Exploratory Objective: Explorative biomarker analysis including the collection of archived tumour tissue and blood sample at baseline and upon progression.
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Cisplatin, Drug : 5-Fluorouracil (5-FU), Drug : Carboplatin, Drug : Paclitaxel

Study Arm Groups : Arm A, Arm A, Arm B, Arm B

Intervention Type
See Interventions above
Primary Outcome Measures
    Best overall response rate by 24 weeks post treatment; 24 weeks
Secondary Outcome Measures
    Feasibility of conducting a multicentre, international study on squamous cell carcinoma of the anus and recruiting within a reasonable time frame.; 3 years; Toxicity; Toxicity will be analysed once all patients have been followed up for at least 4 weeks post treatment.; Progression-free survival; PFS will be analysed once all patients have been followed up for at least 12 months post treatment.; Overall survival; Overall survival will be analysed once all patients have been followed up for at least 12 months post treatment.; Disease control rate; 12 and 24 weeks post treatment start; Best overall response rate of non-irradiated lesions; 24 weeks post treatment start; Anti-tumour activity and magnitude of tumour response; 24 weeks; Quality of Life; 3 years; Identification of potential tumour biomarker; 3 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
80
Participant Inclusion Criteria
    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 Performance status ≤2.

    4. Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1.

    5. Previous definitive chemoradiotherapy 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) ≥1.5x10^9/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.

    8. Fertile men and women must agree to take adequate contraceptive precautions during, and for at least six months after therapy.

    9. Life expectancy of at least 3 months.

    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. Known peripheral neuropathy ≥ grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible).

    15. Pre-existing hearing impairment.

    16. Patients planning for a live vaccine.

    17. Pregnant or lactating females.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Trial Contact(s)
Primary Trial Contact
Sheela Rao, MD, FRCP
1380 +44 (0) 0208 642 6011
Other Trial Contacts
Francesco Sclafani, MD
1293 +44 (0)) 0208 642 6011
Countries Recruiting
Australia, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
EudraCT Number
Not available for this trial
Funder(s)
  • Cancer Research UK
  • Australasian Gastro-Intestinal Trials Group
  • ECOG-ACRIN Cancer Research Group
  • European Organisation for Research and Treatment of Cancer - EORTC
  • International Rare Cancers Initiative (IRCI ) This study is indorsed by IRCI
Other Study ID Numbers
CCR 3847 InterAACT
Sponsor(s)
Royal Marsden NHS Foundation Trust
Key Dates

Recruitment Start Date

Dec 2013

Recruitment End Date

Aug 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

13 Jan 2014

Date updated in source

03 Nov 2015