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Trabectedin/Caelyx vs Cisplatin Hypersensitivity in Relapsed Ovarian Cancer Patients Allergic to Platinum

NCT05512676CompletedOBSERVATIONAL

Summary

Observational, clinical study. Intention to include 40 patients (20 patients treated with trabectedin and 20 with cisplatin hypersensitivity) The investigators investigate the role of trabectedin in combination with PLD and cisplatin in treating platinum sensitive ROC being allergic to carboplatin. The investigators focus on adverse events and evaluate if these are tolerable for the patients and further evaluate the measurable treatment effect on the tumor burden.

Key Facts

Lead Sponsor

Oslo University Hospital

Enrollment

Start Date

2016-03-07

Completion Date

2019-05-20

Study Type

OBSERVATIONAL

Official Title

Trabectedin (T) in Combination With Pegylated Liposomal Doxyrubicin (PLD) Compared to Cisplatin Hypersensitivity (CH) Treatment in Recurrent Ovarian Cancer Patients Allergic to Carboplatin

Conditions

Ovarian NeoplasmChemotherapeutic ToxicityChemotherapy EffectChemotherapy-induced NeutropeniaChemotherapy-induced Nausea and Vomiting

Eligibility

Age Range

18 Years – 80 Years

Sex

FEMALE

Inclusion Criteria:

* Women with recurrent ovarian cancer and
* allergic reaction to carboplatin or
* other serious side effects to carboplatin

Exclusion Criteria:

\- Patients not treated with carboplatin previously

Outcome Measures

Primary Outcomes

PFS

Progression Free Survival

Time frame: From date of end of recurrent treatment (date of last cycle) with trabectedin/PLD or cisplatin hypersensitivity/paclitaxel until the date of first documented progression or date of death from any cause whichever came first, assessed up to 130 months.

Side effects

Side effects of recurrent treatment from trabectedin/PLD and cisplatin hypersensitivity/paclitaxel.

Time frame: The side effects are assessed until 28 days after each cycle, up to 8 weeks after last cycle with trabectedin or cisplatin hypersensitivity. Each cycle is 28 days until 6 cycles..

Secondary Outcomes

Cancer Specific survival (CSS)

Cancer Specific survival

Time frame: From date of primary diagnosis until date of last observation or death of ovarian cancer, whichever came first, assessed up to 36 years.

Drug Interactions

Interactions between trabectedin/PLD or cisplatin hypersensitivity/paclitaxel and other drugs the patients use during recurrent treatment (Examples: antihypertensive drugs, drugs inhibition of CYP450 2C8/3A4). The drugs are defined as mild increase-moderate increase -severe increase, mild decrease, modereate decrease, and severe decrease (6 categories) of trabectedin, PLD, cisplatin hypersensitivity or paclitaxel effect. The categories are obtained from the Drug Interactions Checker at www.drugs.com.

Time frame: From date of start recurrent treatment with trabectedin/PLD or cisplatin hypersensitivity/paclitaxel until date of last cycle with trabectedin/PLD or cisplatin hypersens/paclitaxel. The data are assessed at each cycle, 2 weeks after each cycle until 6.