Combretastin A-4 phosphate in combination with carboplatin and paclitaxel chemotherapy in patients with advanced cancer
| ISRCTN | ISRCTN57858356 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57858356 |
| EudraCT/CTIS number | 2006-005417-35 |
| Secondary identifying numbers | 2291 |
- Submission date
- 31/03/2010
- Registration date
- 31/03/2010
- Last edited
- 13/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Mr Gavin Shreeves
Scientific
Scientific
Department of Medical Oncology
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
Study information
| Study design | Non-randomised multicentre interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | UKCTC-207 |
| Study objectives | 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(s) | West Hertfordshire Hospitals NHS Trust Local Research Ethics Committee, 21/05/2003, ref: EC2003-31 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/11/2005 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 42 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/11/2005 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Medical Oncology
Northwood
HA6 2RN
United Kingdom
HA6 2RN
United Kingdom
Sponsor information
East and North Hertfordshire Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
England
United Kingdom
| Website | http://www.enherts-tr.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/02ryc4y44 |
Funders
Funder type
Industry
OXiGENE, Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes |
Editorial Notes
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
