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

What Was Tested

The trial (phase 2) is built around Romiplostim.

It had two arms (groups): the experimental arm (experimental) and the placebo arm (placebo comparator).

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

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

21 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women ≥ 18 years of age. Before any study-specific procedure, the appropriate written informed consent must be obtained, according to ICH-GCP, and national/local regulation. Topotecan, d 1-5, q3w. Gemcitabine, d1+8, q3w. Carboplatin / paclitaxel, d1, q3w.

The full record lists 15 inclusion and 17 exclusion criteria; among the exclusions: previous treatment with peg-rhumgdf, recombinant human thrombopoietin (rhutpo), romiplostim, eltrombopag, or another thrombopoietic protein; subjects, who have had a larger surgery within the last 2 weeks before entering this study; active participation in any other clinical study.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Romiplostim study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Romiplostim study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2014-02-01 with completion listed for 2019-01-01.

It ran at 13 sites in Germany (13).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Grade 3 and 4 thrombocytopenia (time frame: At the end of Cycle 1 (each cycle is 28 days)).

It also tracked 10 secondary outcomes, for example Adverse events of grade 3/4, Grade 3/4 thrombocytopenia, Platelet Counts, Bleeding events, Grade 1, 2, 3, or 4 thrombocytopenia (maximum NCI CTC grade by patient) and Grade 3/4 thrombocytopenia.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Romiplostim in 21 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, all human trials.