|
Health Condition(s) or Problem
|
Ovarian Cancer
|
|
Lay Summary
|
The purpose of this study is to determine if weekly chemotherapy (i.e. giving paclitaxel or
carboplatin at a lower dose every week) is more effective than standard chemotherapy
(paclitaxel and carboplatin given once every three weeks over 18 weeks) in treating ovarian
cancer. The investigators also want to see if weekly chemotherapy causes more or fewer
side-effects than standard chemotherapy.
(from ClinicalTrials.gov)
|
|
Who can enter the trial
|
Inclusion Criteria:
- Females aged 18 years or more
- Signed informed consent and ability to comply with the protocol
- Histologically confirmed, with core biopsy from a disease site as minimum
requirement (cytology alone is insufficient for diagnosis):
- Epithelial ovarian carcinoma
- Primary peritoneal carcinoma of Müllerian histological type
- Fallopian tube carcinoma
- FIGO stage IC or above, which may be based on clinical and radiological assessment in
patients who have not undergone immediate primary surgery
- Confirmed high-risk histological subtype for patients with FIGO stage IC/IIA disease,
namely:
- High grade serous carcinoma
- Clear cell carcinoma
- Other histological subtype considered poorly differentiated/grade 3
- ECOG Performance Status (PS) 0-2
- Life expectancy > 12 weeks
- Adequate bone marrow function:
- Absolute Neutrophil Count (ANC) = 1.5 x 109/l
- Platelets (Plt) = 100 x 109/l
- Haemoglobin (Hb) = 9g/dl (can be post transfusion)
- Adequate liver function (within 28 days prior to randomisation):
- Serum bilirubin (BR) = 1.5 x ULN
- 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.
Exclusion Criteria:
- Non-epithelial ovarian cancer, including malignant mixed Müllerian tumours
(carcinosarcomas)
- Peritoneal cancer that is not of Müllerian origin, including mucinous histology
- Borderline tumours (tumours of low malignant potential)
- Prior systemic anti-cancer therapy for ovarian cancer (for example chemotherapy,
monoclonal antibody therapy, tyrosine kinase inhibitor therapy or hormonal therapy)
- Previous malignancies within 5 years prior to randomisation apart from: adequately
treated carcinoma in-situ of the cervix, breast ductal carcinoma in-situ,
non-melanomatous skin cancer; or previous/synchronous early-stage endometrial cancer
defined as stage IA (FIGO 2009) grade 1 or 2 endometrioid cancers with no
lymphovascular space invasion
- Pre-existing sensory or motor neuropathy grade = 2
- Evidence of any other disease/metabolic dysfunction that in the opinion of the
investigator would put the subject at high-risk of treatment-related complications or
prevent compliance with the trial protocol
- Planned intraperitoneal cytotoxic chemotherapy
- Any previous radiotherapy to the abdomen or pelvis
- Sexually active women of childbearing potential not willing to use adequate
contraception (e.g. oral contraceptives, intrauterine device or barrier method of
contraception in conjunction with spermicidal jelly or surgically sterile) for the
study duration and at least six months afterwards
- Pregnant or lactating women
- Treatment with any other investigational agent prior to protocol defined progression
- Known hypersensitivity to carboplatin, paclitaxel or their excipients (including
cremophor)
- History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI
of the brain is mandatory in the case of suspected brain metastases. Spinal MRI is
mandatory in the case of suspected spinal cord compression. Patients with brain or
meningeal metastases are not eligible
|
|
Who cannot enter the trial
|
Inclusion Criteria:
- Females aged 18 years or more
- Signed informed consent and ability to comply with the protocol
- Histologically confirmed, with core biopsy from a disease site as minimum
requirement (cytology alone is insufficient for diagnosis):
- Epithelial ovarian carcinoma
- Primary peritoneal carcinoma of Müllerian histological type
- Fallopian tube carcinoma
- FIGO stage IC or above, which may be based on clinical and radiological assessment in
patients who have not undergone immediate primary surgery
- Confirmed high-risk histological subtype for patients with FIGO stage IC/IIA disease,
namely:
- High grade serous carcinoma
- Clear cell carcinoma
- Other histological subtype considered poorly differentiated/grade 3
- ECOG Performance Status (PS) 0-2
- Life expectancy > 12 weeks
- Adequate bone marrow function:
- Absolute Neutrophil Count (ANC) = 1.5 x 109/l
- Platelets (Plt) = 100 x 109/l
- Haemoglobin (Hb) = 9g/dl (can be post transfusion)
- Adequate liver function (within 28 days prior to randomisation):
- Serum bilirubin (BR) = 1.5 x ULN
- 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.
Exclusion Criteria:
- Non-epithelial ovarian cancer, including malignant mixed Müllerian tumours
(carcinosarcomas)
- Peritoneal cancer that is not of Müllerian origin, including mucinous histology
- Borderline tumours (tumours of low malignant potential)
- Prior systemic anti-cancer therapy for ovarian cancer (for example chemotherapy,
monoclonal antibody therapy, tyrosine kinase inhibitor therapy or hormonal therapy)
- Previous malignancies within 5 years prior to randomisation apart from: adequately
treated carcinoma in-situ of the cervix, breast ductal carcinoma in-situ,
non-melanomatous skin cancer; or previous/synchronous early-stage endometrial cancer
defined as stage IA (FIGO 2009) grade 1 or 2 endometrioid cancers with no
lymphovascular space invasion
- Pre-existing sensory or motor neuropathy grade = 2
- Evidence of any other disease/metabolic dysfunction that in the opinion of the
investigator would put the subject at high-risk of treatment-related complications or
prevent compliance with the trial protocol
- Planned intraperitoneal cytotoxic chemotherapy
- Any previous radiotherapy to the abdomen or pelvis
- Sexually active women of childbearing potential not willing to use adequate
contraception (e.g. oral contraceptives, intrauterine device or barrier method of
contraception in conjunction with spermicidal jelly or surgically sterile) for the
study duration and at least six months afterwards
- Pregnant or lactating women
- Treatment with any other investigational agent prior to protocol defined progression
- Known hypersensitivity to carboplatin, paclitaxel or their excipients (including
cremophor)
- History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI
of the brain is mandatory in the case of suspected brain metastases. Spinal MRI is
mandatory in the case of suspected spinal cord compression. Patients with brain or
meningeal metastases are not eligible
|
|
What will happen
|
Drug; Carboplatin; AUC5 by intravenous infusion over 30-60 minutes; Arm 1 (Control Arm); Arm 2 (Research arm); Drug; Carboplatin; AUC2 by intravenous infusion over 30-60 minutes; Arm 3 (Research arm); Drug; Paclitaxel; 175mg/m2 by intravenous infusion over 3 hours; Arm 1 (Control Arm); Drug; Paclitaxel; 80mg/m2 by intravenous infusion over 1 hour; Arm 2 (Research arm); Arm 3 (Research arm)
|
|
Primary aim
|
Stage 1: Feasibility assessed as the number of cycles and dose intensity of protocol treatment delivered per patient.; Stage 1: Safety assessed as the rate of any = grade 3 toxicity experienced per patient.; Stage 2: Progression Free Survival rate at 9 months after randomisation; Stage 3: Progression Free Survival; Stage 3: Overall Survival
|
|
Secondary Aim
|
Stage 3: Toxicity assessed by number of participants with adverse events; Expected 1 year and 3 years after last patient is randomised.; No; Assessment of toxicity profile of dose-fractionated chemotherapy; Stage 3: Quality of Life; Expected 1 year and 3 years after last patient is randomised.; No; Assessment of potential impact of dose-fractionated chemotherapy on functionality and well-being in patients undergoing first line treatment for ovarian cancer.; Stage 3: Health Economics; Expected 1 year and 3 years after last patient is randomised.; No; Cost-effectiveness analysis of dose-fractionated chemotherapy
|
|
Participant Information Sheet
|
Sorry, not currently available
|
|
Website
|
http://www.icon8trial.org
|
|
Recruitment Status
|
Recruiting
|
|
Nation
|
England
|
|
Location
|
London
|