Ovarian Cancer
Conditions
Brief summary
Time to progression (physical examination and radiologic imaging
Interventions
DRUGPaclitaxel
4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
Sponsors
North Eastern German Society of Gynaecological Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with primary ovarian cancer * ECOG- 0-2 * Age \>= 18 * no chemotherapy, radiation or immunotherapy in medical history for ovarian cancer * adequate bone marrow, liver and kidney reserve: leukocytes ≥ 2.0 x 109/l, platelets ≥ 100 x 109/l, bilirubin \<= 2,0 mg%, creatinine \<= 1,5 mg% or creatinine clearance ≥ 60 ml/ min, hemoglobin ≥ 9 g/ dl SGOT, SGPT an AP within 3 fold of the reference laboratory's normal range * written informed consent
Exclusion criteria
* before-existing heart illness, Cardiac infarct within last 6 months * Radiotherapy within 4 weeks for study entry * Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intrauterine devices, surgical methods of sterilization, or, in hormone insensitive tumors only, oral, subcutaneous or transvaginal hormonal, non-estrogen containing contraceptives)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25% | every 3 months for up to 3 years | Time to progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years | defined as hematological and non-hematological adverse events of grade \>= grade 1 |
Participant flow
Recruitment details
recruitment period: July 2003 - December 2004
Participants by arm
| Arm | Count |
|---|---|
| Paclitaxel Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol® | 105 |
| Total | 105 |
Baseline characteristics
| Characteristic | Paclitaxel |
|---|---|
| Age, Continuous | 60.4 years |
| Gender Female | 105 Participants |
| Gender Male | 0 Participants |
| Region of Enrollment Germany | 105 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 105 / 105 |
| serious Total, serious adverse events | 13 / 105 |
Outcome results
Primary
Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%
Time to progression
Time frame: every 3 months for up to 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paclitaxel | Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25% | 28.8 months |
Secondary
Toxicity
defined as hematological and non-hematological adverse events of grade \>= grade 1
Time frame: after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel | Toxicity | 105 participants |