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Chemo-Immunotherapy: Observational Trial of Carboplatin-pegylated Liposomal Doxorubicin (PLD) or Doxorubicin Combination Chemotherapy With Tocilizumab, a Humanized Monoclonal Antibody Against the Human Interleukin-6 (IL-6) Receptor, and Pegylated Interferon Alpha (Peg-Intron) for Patients With Recurrent Ovarian Cancer.


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Recurrent Ovarian Cancer

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Trial Information

Chemo-Immunotherapy: Observational Trial of Carboplatin-pegylated Liposomal Doxorubicin (PLD) or Doxorubicin Combination Chemotherapy With Tocilizumab, a Humanized Monoclonal Antibody Against the Human Interleukin-6 (IL-6) Receptor, and Pegylated Interferon Alpha (Peg-Intron) for Patients With Recurrent Ovarian Cancer.


Inclusion Criteria:



- Histologically proven epithelial ovarian cancer

- Progression of disease or relapse after previous therapy with platinum

- Measurable disease (RECIST 1.1) or elevated CA125 > 2 times the upper normal limit
(UNL) within 3 months and confirmed

- Age ≥18 years

- WHO performance status 0-2

- Adequate bone marrow function: WBC ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets
≥100 x 109/l

- Adequate liver function: bilirubin ≤1.5 x UNL range, ALAT and/or ASAT

- 2.5 x UNL (<5x UNL in case of liver metastases), Alkaline Phosphatase ≤5 x UNL

- Adequate renal function: the calculated creatinine clearance should be

- 50 mL/min

- Survival expectation > 3 months

- Patients must be accessible for treatment and follow-up

- Written informed consent according to the local Ethics Committee requirements

Exclusion Criteria:

- Chemotherapy within past 3 months

- Previous malignancy within 5 years, with exception of a history of a previous basal
cell carcinoma of the skin or pre-invasive carcinoma of the cervix

- Serious other diseases as recent myocardial infarction, clinical signs of cardiac
failure or clinically significant arrhythmias

- Known hypersensitivity reaction to any of the components of the treatment

- Pregnancy or lactating

- Medical or psychological condition which in the opinion of the investigator would not
permit the patient to complete the study or sign meaningful informed consent

- Infection with tuberculosis and hepatitis B or C

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The feasibility (NCI-CTCv4.0) to combine carboplatin and PLD or doxorubicin with tocilizumab as well as with tocilizumab and Peg-Intron

Outcome Description:

The safety (NCI-CTCv4.0)and efficacy (immune-monitoring)of the new combination will be measured .

Outcome Time Frame:

two years

Safety Issue:

Yes

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

PITCH trial

NCT ID:

NCT01637532

Start Date:

February 2011

Completion Date:

September 2014

Related Keywords:

  • Recurrent Ovarian Cancer
  • Ovarian Neoplasms

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