Plain English Summary
Trial website
Additional identifiers
EudraCT number
2006-005417-35
ClinicalTrials.gov number
Protocol/serial number
2291
Study information
Scientific title
A phase Ib/II trial of CA4P (combretastin A-4 phosphate) in combination with carboplatin and paclitaxel chemotherapy in patients with advanced cancer and advanced ovarian carcinoma
Acronym
UKCTC-207
Study hypothesis
1. To assess safety and tolerability of the CA4P-carboplatin-paclitaxel combination in relapsed platinum-resistant ovarian/primary peritoneal cancer
2. To gather preliminary data on the anti-tumour efficacy of the CA4P-carboplatin-paclitaxel combination in relapsed platinum-resistant ovarian/primary peritoneal cancer
Ethics approval
West Hertfordshire Hospitals NHS Trust Local Research Ethics Committee, 21/05/2003, ref: EC2003-31
Study design
Non-randomised multicentre interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Ovary
Intervention
6 cycles (3-weekly) of:
Day 1: combretastatin A-4 phosphate 63 mg/m^2 intravenously (i.v.)
Day 2: paclitaxel 175 mg/m^2 i.v. then carboplatin AUC 5 i.v.
Follow-up every 2 months until progression or death.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
1. Computed tomography (CT) scans, measured at screening, after cycle 2, after cycle 4 and after cycle 6
2. CA-125 tumour marker, measured at screening and before every cycle
Secondary outcome measures
1. Duration of response
2. Progression-free survival
3. Toxicity
Clinical examination for signs of progression is assessed at every follow-up.
Overall trial start date
15/11/2005
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. A minimum four-week interval must have passed from the time a patient last received chemotherapy, immunotherapy or radiotherapy prior to the first dose of study drugs (six weeks for therapy known to be associated with delayed toxicity such as nitrosoureas or mitomycin-C)
2. For entry into the phase II study: patients with Ovarian, Primary Peritoneal or Fallopian Tube Cancer who have relapsed following treatment with a platinum containing regime in the adjuvant or metastatic setting, with a progression-free interval (FPI) of less than 6 months.
3. Radiologically measurable disease and/or evaluable by Ca 125. To be evaluable for response by CA-125 requires 2 pre-treatment samples greater than twice the upper limit of normal.
4. Age 18 years or older
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2
6. Life expectancy greater than 12 weeks
7. Adequate bone marrow function:
7.1. Absolute granulocyte count (neutrophils and bands) greater than 1500 cells/mm^3
7.2. Platelet count greater than 100,000 cells/mm^3
8. Adequate hepatic function:
8.1. Total bilirubin less than 1.5 mg/dl
8.2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 2.5 x upper limit of normal
9. Adequate renal function: Glomerular Filtration Rate measured by EDTA
clearance greater than 50 ml/min
10. Patients must provide written and voluntary informed consent and be available for periodic follow-up
11. Fertile patients must abstain from sexual intercourse or use effective birth control
12. All women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test documented within 72 hours prior to receiving cycle 1
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 42
Participant exclusion criteria
1. Serious intercurrent infection(s) or other nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardised by the complications of this therapy
2. Grade 2 (CTC v 3.0) or greater pre-existing peripheral neuropathy (motor or sensory)
3. Active brain metastasis, including symptomatic involvement, evidence of cerebral oedema by CT or MRI, radiographic evidence of progression since definitive therapy, or continued requirement for corticosteroids
4. Major surgery within four weeks prior to receiving cycle 1
5. Symptomatic peripheral vascular disease or cerebrovascular disease
6. Prior radiation involving > 30% of the bone marrow
7. Patients who have had any clinically apparent ischaemic or vascular damage from previous radiotherapy. Patients who have had radical radiotherapy to the thorax or abdomen at any time or post-operative radical radiotherapy to the pelvis. Palliative radiotherapy treatments are acceptable. Patients with rectal primaries who have received pre-operative pelvic radiotherapy or chemoradiation are eligible if the small bowel was mobile and not stuck to the tumour.
8. Psychiatric disorders or other conditions rendering patients incapable of complying with the requirements of the protocol
9. Pregnant or breast-feeding women
10. History of angina (stable or more severe, even if controlled with medications), myocardial infarction, CHF, non-controlled atrial arrhythmias or clinically significant arrhythmias including conduction abnormality, nodal junctional arrhythmias and dysrhythmias, sinus bradycardia or tachycardia, supraventricular arrhythmias, atrial fibrillation or flutter, syncope or vasovagal episodes
11. MUGA scan revealing significant heart wall abnormality or heart muscle damage
12. Uncontrolled hypertension (defined as blood pressure consistently greater than 150/100 irrespective of medication)
13. Uncontrolled hypokalemia and/or hypomagnesemia
14. ECG with evidence of prior myocardial infarction (e.g., significant Q waves), QTc > 450 msec or other clinically significant abnormalities
15. Patients taking any drug(s) known to prolong the QTc interval, which cannot be interrupted for at least four days during each 21-day treatment cycle. Patients with conditions associated with QTc prolongation
16. Concurrent investigational therapy
17. Concurrent antineoplastic therapy (radiation therapy, cytotoxic or biologic therapy)
18. Concurrent hormonal therapy with the exception of GnRH agonists in patients with hormone refractory prostate cancer, HRT, oral contraceptives, and megestrol acetate used for anorexia/cachexia
19. Receiving anticoagulation with warfarin, heparin or low molecular weight heparin other than low dose (1 mg) warfarin for maintenance of Hickman line patency
20. No previous high-dose chemotherapy with autologous bone marrow transplant (HDC-ABMT) or similar high-dose therapies
Recruitment start date
15/11/2005
Recruitment end date
31/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Medical Oncology
Northwood
HA6 2RN
United Kingdom
Sponsor information
Organisation
East and North Hertfordshire Hospitals NHS Trust (UK)
Sponsor details
Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
OXiGENE, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list