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BIO Magazine - ICON 8 Δεκέμβριος 2015
Δεκέμβριος 2015 No38

BIO Health

ICON 8
ICON 8

Ovarian cancer is the forth most common cancer in women and is usually treated by a combination of surgery and standard chemotherapy (usually combination of carboplatin and paclitaxel) given once every three weeks for 6 cycles. Recent studies have suggested that giving chemotherapy more frequently than once every 3 weeks is also effective. This type of treatment, known as dose-fractionated chemotherapy involves giving paclitaxel or carboplatin at a lower dose every week during treatment (ICON 8). 

Aim 

To find out if weekly chemotherapy is more effective than standard chemotherapy treatment in ovarian cancer and if it causes more or fewer side-effects than standard chemotherapy. Although weekly chemotherapy involves more doses of chemotherapy than standard chemotehrapy, the treatment couse is the same length for both. 

Inclusion criteria 

  • Diagnosis of ovarian cancer, fallopian tube cancer or primary peritoneal cancer Cancer stage > Ic, if the cancer is stage Ic or IIa, it must also be either a high grade serous cancer, a clear cell cancer, or another type that is poorly differentiated)
  • Performance status 0, 1 or 2
  • Life expectancy > 12 weeks
  • Adequate bone marrow function:
  1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/l
  2. Platelets (Plt) ≥ 100 x 109/l
  3. Haemoglobin (Hb) ≥ 9g/dl (can be post transfusion)
  • Adequate liver function (within 28 days prior to randomisation):
  1. Serum bilirubin (BR) ≤ 1.5 x ULN
  2. Serum transaminases ≤ 3 x ULN in the absence of parenchymal liver metastases or ≤ 5 x ULN in the presence of parenchymal liver metastases
  • Adequate renal function as defined by GFR (Glomerular Filtration Rate) ≥ 30ml/min. Female > 18 years old

 Exclusion criteria 

  • Cancer with central nervous system metastasis
  • Mixed mullerian tumor, non epithelial ovarian cancer or borderline tumour
  • History of chemotherapy. biological therapy or hormone therapy for ovarian cancer
  • History of any other cancer in the last 5 years apart from DCIS, carcinoma in situ cervix or non melanoma skin cancer that have been successfully treated, or endometrial cancer stage IA and low grade
  • History of abdominal or pelvic radiotherapy
  • Plan for intraperitoneal chemotherapy
  • Peripheral neuropathy
  • Having any other experimental drug
  • Sensitivity to carboplatin and paclitaxel, or their ingredients
  • Pregnancy or breastfeeding
  • Sexually active women of childbearing potential not willing to use adequate contraception for the study duration and at least six months afterwards.

The patients are randomised schematically as following:

 

 

A patient can withdraw, or be withdrawn, from ICON 8 for the following reasons:

  • Progression whilst on treatment
  • Unacceptable toxicity
  • Intercurrent illness which prevents further treatment
  • Withdrawal of consent for treatment by the patient
  • Any alterations in the patient’s condition which justifies the discontinuation of treatment in the investigator’s opinion

Christos Iavazzo MD, MSc, PhD

Senior Clinical Fellow Gynaecological Oncology Department, Royal Surrey County Hospital, Guildford, United Kingdom

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