Combretastin A-4 phosphate in combination with carboplatin and paclitaxel chemotherapy in patients with advanced cancer
- Conditions
- Topic: National Cancer Research NetworkSubtopic: Gynaecological CancerDisease: OvaryCancerOvarian cancer
- Registration Number
- ISRCTN57858356
- Lead Sponsor
- East and North Hertfordshire Hospitals NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 42
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method