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


Phase 3
18 Years
N/A
Not Enrolling
Female
Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum, Platinum Sensitve Relapse, Anemia

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reduction of anemia

Principal Investigator

Christian Jackisch, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

AGO Study Group

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AGO-OVAR 2.7

NCT ID:

NCT00189371

Start Date:

February 2004

Completion Date:

December 2005

Related Keywords:

  • Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum
  • Platinum Sensitve Relapse
  • Anemia
  • Anemia
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

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