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Phase 2
18 Years
75 Years
Open (Enrolling)
Female
Ovarian Cancer With Malignant Ascites

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Trial Information


Inclusion Criteria:



- Signed informed consent obtained prior to initiation of any study-specific procedures
and treatment as confirmation of the patient's awareness and willingness to comply
with the study requirements.

- Histologically confirmed and documented ovarian cancer with malignant ascites.

- ECOG(Eastern Cooperative Oncology Group, ECOG) PS 0-2.

- Life expectancy of >3 months.

- No serious inadequate bone marrow function, liver and renal function or significant
cardiovascular disease.

Exclusion Criteria:

- Known hypersensitivity to any of the study drugs or excipients.

- Any current anti-cancer therapy.

- No evidence of ascites.

- Key organ dysfunction.

- Significant cardiovascular disease (e.g. congestive heart failure (CHF), uncontrolled
cardiac arrhythmia, angina, heart valve disease, myocardial infarction and refractory
hypertension need to be long time controlled by medicine).

- Non-healing wound, ulcer or bone fracture.

- Uncontrolled psychiatric history.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

objective response rate

Outcome Time Frame:

24month

Principal Investigator

Zhao Hui, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese PLA General Hospital

Authority:

China: Food and Drug Administration

Study ID:

ML25396

NCT ID:

NCT01838538

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Ovarian Cancer With Malignant Ascites
  • Ascites
  • Ovarian Neoplasms

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