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Genital Diseases

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

standard chemotherapy at 3/4-weekly intervals (cf. inclusion criteria) + romiplostim 750 μg sc once per week for up to 4 cycles

standard chemotherapy at 3/4-weekly intervals (cf. inclusion criteria) + placebo once per week for up to 4 cycles

Standard chemotherapy

Romiplostim

Placebos

Jalid Sehouli, Prof. Dr. med.

To evaluate the safety of secondary chemotherapy induced thrombocytopenia (reduction in platelets which leads to bleeding) prophylaxis with romiplostim in ovarian cancer subjects receiving myelosuppressive (blood cell damaging) chemotherapy.It is anticipated that Romiplostim, when administered at an effective dose and schedule, will be a well-tolerated treatment for subjects experiencing chemotherapy-induced thrombocytopenia.

Chemotherapy of recurrent ovarian cancer leads to severe thrombocytopenia in a considerable proportion of the patients, requiring treatment delays or dose reductions, and placing the patient at a high risk of bleeding complications. The amount of thrombocytopenia is highly schedule-dependent. In platinum-sensitive ovarian cancer that relapsed more than 6 months after end of primary therapy, a platinum containing reinduction therapy - the combination of paclitaxel/carboplatin, gemcitabine/carboplatin or PLD/carboplatin - is recommended according to the current AGO guidelines or recent ASCO presentations. Especially the latter two regimens often induce severe and even dose-limiting myelosuppression, including thrombocytopenia. Therefore, prophylaxis, or at least secondary prophylaxis of this toxicity is an important goal of supportive therapy. The use of platelet transfusions is limited by cost, supply problems, and associated risks, such as transfusion reactions, transmission of infection, and alloimmunization and platelet refractoriness. In contrast to the situation for the red and white blood cell compartments, the implementation of growth factor treatment in order to ameliorate the therapy of thrombocytopenia and its complications, is yet very limited. Romiplostim is an active second-generation thrombopoietic agent without safety problems due to immunogenicity, which proved to be beneficial in the treatment of immune thrombocytopenic purpura and myelodysplastic syndromes. The rationale of this trial is to obtain evidence that romiplostim can improve platelet counts/recovery in the treatment of recurrent ovarian cancer. Due to the fact, that the expected occurrence of severe thrombocytopenia and its complications may heavily depend on the selection of patient and their characteristics such as actually chosen treatment schedule, tumor stage, extent of metastasis, pre-treatment etc. a phase II design comparing the results to historical data or expectations is insufficient. A simple within-group control design, comparing subsequent cycles of the same patients with or without the supportive experimental drug may also be flawed, as "spontaneous" improvements after obviously unchanged chemotherapy are often observed. With some regimens, the first cycle proves to be generally more toxic than later ones. On the other hand, regimens may result in cumulative myelosuppression. A design including a randomized doubleblind control group is therefore warranted, moreover, as platelet counts represent a sensitive and valid surrogate marker for a clinical benefit. The current study will employ a model of secondary prophylaxis. The enrolment of subjects with grade 3 and/or 4 thrombocytopenia will facilitate an assessment of the ability of romiplostim to impact thrombocytopenia at clinically significant levels, which warrant the administration of platelet transfusions, dose reduction, and dose delay.

74 patients (about 37 in the experimental and 37 in the placebo arm), evaluable for the principal efficacy endpoint, are required. These will be recruited from an expected number of 15 sites.

Patients With Relapsed Ovarian Cancer (2nd and 3rd Line) Treated With Chemotherapy According to AGO Guidelines

Double-blind, Placebo-controlled Multicenter Phase II Trial to Evaluate the Efficacy and Safety of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Subjects With Relapsed Ovarian Cancer (2nd or Further Line)

Platelet Count (100 x 10\^9/L) will be measured and the rate will be compared by Treatment Group

Determine the rate of AE between the experimental arm and the placebo arm.

The rate of AE between the experimental arm and the placebo arm will be determined

The average platelet nadir in each treatment Group will be considered

The proportion of patients suffering from grade 1, 2, 3, or 4 bleeding Events will be considered

Determine the proportion of subjects in each treatment group

The number of subjects in each treatment Group will be considered

The platelet counts on study chemotherapy treatment cycles by treatment group will be considered.

The proportion of subjects able to receive all CT cycles on time by treatment group

Spots Global Cancer Trial Database for nplate

Every month we try and update this database with for nplate cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nplate

Every month we try and update this database with for nplate cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nplate cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.