Anemia, Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum, Platinum Sensitve Relapse
Conditions
Brief summary
Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Relapse more than 6 months following first line chemotherapy is regarded as platinum/taxane sensitive disease. Reinduction chemotherapy with platinum/taxane is known to be an effective treatment option. Therapy induced anemia is a common problem resulting in decrease of quality of life. The rationale of this trail is to evaluate the effects of epoetin alpha on reduction of therapy induced anemia, rate of transfusions and on quality of life.
Interventions
DRUGpaclitaxel, carboplatin, epoetin alpha
Sponsors
AGO Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
* Relapse longer than 6 months after termination of platinum/taxane based first line chemotherapy * Previously histologically confirmed cancer of: ovary, fallopian tube, peritoneum * measurable and evaluable lesions by ultrasound, computer-tomography or MRI * Performance status ECOG \< 2 or karnofsky index \> 60% * normal organ function
Exclusion criteria
* more than 1 chemotherapy prior enrollment * ongoing treatment with epoetin alpha or related drugs * history of thrombosis or embolism during the past 12 months prior enrollment * ileus * left ventricular failure \> NYHA classification \> 2 * Ongoing toxicity of any kind (\> CTC Grad II)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of anemia | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life | — |
| Overall survival | — |
| Progression free survival | — |
| Toxicity | — |
Countries
Germany
Outcome results
None listed