The main purpose of this research study is to find out if treatment of late relapse with liposomal doxorubicin (Caelyx) combined with carboplatin will control the tumor growth at least as well as standard treatment of paclitaxel and carboplatin.…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective
• Progression-free survival (PFS) between both treatment groups
Secondary outcome
Secondary objectives
• Overall survival (OS)
• Toxicities
• Quality of life (QOL)
Background summary
Liposomal doxorubicin (Caelyx) is a new drug which has been shown to cause
shrinkage or stabilization of the size of recurrent ovarian tumors in some
patients and can be combined safely with carboplatin. Side effects observed
with the combination of liposomal doxorubicin (Caelyx) and carboplatin are
different from those observed with paclitaxel and carboplatin.
Study objective
The main purpose of this research study is to find out if treatment of late
relapse with liposomal doxorubicin (Caelyx) combined with carboplatin will
control the tumor growth at least as well as standard treatment of paclitaxel
and carboplatin. This study will look at the side effects of each combination.
It is hoped that substituting paclitaxel with Caelyx in combination with
carboplatin will improve the tolerance of the treatment program with at least
the same efficacy and fewer side effects.
Study design
This is an open-label, multi-center, multi-national Intergroup, controlled,
randomized Phase III trial comparing Caelyx / Carboplatin vs. Paclitaxel /
Carboplatin in the treatment of patients with epithelial ovarian cancer in late
relapse. The patients will be randomized to either of the following treatments:
1. STUDY GROUP: CAELYX-CARBOPLATIN
2. CONTROL GROUP: PACLITAXEL-CARBOPLATIN
A 3-week schedule defines a course of treatment.
Intervention
Starting dose of Caelyx - Carboplatin Caelyx 30 mg/m2 day 1 Carboplatin AUC 5
day 1 q 28 days / 6 courses or to progression Starting dose of Paclitaxel -
Carboplatin Paclitaxel 175 mg/m2 day 1 Carboplatin AUC 5 day 1
q 21 days / 6 courses or to progression
Study burden and risks
Lowering of blood cell counts is a common side effect of liposomal doxorubicin
(Caelyx) carboplatin and paclitaxel. Other common side effects that may occur
are: numbness and tingling in the hands and feet that may lead to difficulty
walking, buttoning clothes; hair loss; nausea; vomiting. Occasional side
effects could be: allergic reactions; taste changes; alopecia; pain; asthenia;
ulceration of the skin if the drug escapes from the vein; muscle and/or joint
aches; skin irritation and tenderness at the injection site; allergic reactions
with hives; wheezing and low blood pressure; sores in the mouth; tiredness;
taste changes; nausea and vomiting; diarrhea; inflammation of the colon and
intestine; abnormalities in heart rate, such as a slow regular pulse (a slow
pulse is not harmful; however, if you should develop any other irregularities
in heart rate during treatment, an electrocardiogram and other tests may be
required); mouth sores; skin rashes on the soles of feet and palms of hands and
along skin folds; blistering and ulceration may also occur but are rare; hair
loss; asthenia, loss of appetite.
Ospedale Mauriziano Umberto I, Cattedra de Ginecologica, Largo Turati 62
I-10128 Torino
Italie
Ospedale Mauriziano Umberto I, Cattedra de Ginecologica, Largo Turati 62
I-10128 Torino
Italie
Listed location countries
Age
Inclusion criteria
- Patients aged > 18 years
- Patients with a histological proven diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors
- Patients with measurable disease (RECIST criteria) or CA 125 assessable disease (GCIG criteria) or with histological proven diagnosis of relapse
- Patients with disease in progression > 6 months after a first or second platinum-based line. Patients should have previously received a taxane derivative
- Patients with ECOG performance status < 2
- Patients with a life-expectancy of at least 12 weeks
- Adequate bone marrow, renal and hepatic function defined as
• WBC > 3.0 x 109/l or Neutrophils (*ANC) >= 1,5 × 109 /l
*Absolute Neutrophil Count
• Platelets >= 100 × 10 9/l
• Hemoglobin > 6 mmol/l (> 10,0 mg/dl)
• Bilirubin <= 2 × upper normal limit of normal range
• Estimated glomerular filtration rate >= 40 ml/min according to Cockroft-Gault formula
Exclusion criteria
- brain metastases
- heartdesease
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2004-004456-39-NL |
| CCMO | NL12184.041.06 |