Phase I-II-III studies of Cisplatin and Combretastatin (CA4P) in recurrent or advanced servical cancer
- Conditions
- Metastatic or recurrent cervical cancer
- Registration Number
- EUCTR2004-001356-37-DK
- Lead Sponsor
- ordic Society for Gynecological Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 420
a) Primary advanced (stage IVB), persistent or recurrent cancer of the uterine cervix considered incurable by surgery, radiotherapy and or chemotherapy.
b) Histological verified squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
c) Performance status (WHO) 0 or 1.
d) Life expectancy > 12 weeks.
e) Age > 18 years and < 75 years.
f) For Phase I, a treatment free interval of at least 2 month from previous radiotherapy, chemotherapy or radio-chemotherapy is required.
g) For Phase II, at least one measurable lesion (RECIST) outside previously irradiated area with clinical evidence of progression within 6 weeks prior to treatment is required. Progressing lesions localized only to previous irradiated volume is allowed in Phase III.
h) For Phase II-III, prior chemotherapy or radio-chemotherapy is allowed provided that a treatment free interval of at least 6 month is at hand. Previous radiotherapy more than 3 month ago is allowed.
i) For Phase II-III, patients progressing directly during previous chemotherapy or radio-chemotherapy are ineligible.
j) Acceptable bone marrow function (leukocytes ³ 3.0x109/L and platelet count 100x109/L).
k) ECG without evidence of prior myocardial infarction (e.g., significant Q waves), QTc > 450 msec. or other clinically significant abnormalities.
l) Sufficient kidney function with calculated (Cockroft-Gault) GFR > 50 ml/min and no uncontrolled hypokalemia and/or hypomagnesemia.
m) Acceptable liver function with bilirubin < 30 µmol/l.
m) Patients with childbearing potential must have a negative pregnancy test and should use an effective method of contraception (hormonal anticonception or intrauterine device).
n) Written informed consent according to ICH/EU GCP guidelines and regional and national law.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
a) No combination of protocol treatment with attempts of curative surgery or radiotherapy.
b) No previous inclusion in the protocol.
c) No other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin.
d) No CNS metastases.
e) No major surgery within 4 weeks.
f) No concomitant administration of other antineoplastic agents.
g) No palliative radiotherapy unless at least one measurable lesion is left unirradiated.
h) No history of angina (stable or more severe, even if controlled with medications), myocardial infarction, chronic heart failure, 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.
i) Patients taking any drug(s) known to prolong the QTc interval, which cannot be interrupted for at least four days during each 7-day treatment cycle or patients with conditions associated with QTc prolongation cannot be included
j) No uncontrolled hypertension (defined as blood pressure consistently greater than 150/100 mmHg irrespective of medication).
k) No symptomatic peripheral vascular disease or cerebrovascular disease.
l) No grade 2 (CTC v.3.0) or greater pre-existing peripheral neuropathy (motor or sensory);
m) No psychiatric disorders or other conditions rendering patients incapable of complying with the requirements of the protocol.
n) No active infection or other severe medical condition endangering treatment delivery.
o) Patients, for whom regular follow-up attendance is impractical, are not eligible.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method