Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum

AGO Study Group

Status and phase

Terminated

Phase 3

Conditions

Anemia

Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum

Platinum Sensitve Relapse

Treatments

Drug: paclitaxel, carboplatin, epoetin alpha

Study type

Interventional

Funder types

Other

Identifiers

NCT00189371

AGO-OVAR 2.7

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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