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

NCT05512676 | Completed

• 1 other identifier: 2015/2167 REK sør-øst B
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ovarian Neoplasm; Chemotherapeutic Toxicity; Chemotherapy Effect; Chemotherapy-induced Neutropenia; Chemotherapy-induced Nausea and Vomiting

Keywords

Ovarian cancer; Pegylated Liposomal Doxorubicin; Trabectedin; Cisplatin hypersensitivity; Paclitaxel

Outcome Measures

Primary Outcomes (2)

• PFS

  Progression Free Survival

  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.

  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 (2)

• Cancer Specific survival (CSS)

  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

  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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Only women included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Inclusion of 20 patients treated with trabectedin and pegylated liposomal doxorubicin after at least one line of previous chemotherapy. * Inclusion of 20 patients treated with cisplatin hypersensitivity and paclitaxel after at least one line of previous chemotherapy * All patients treated at Oslo University Hospital, Dept. Gyn. Oncology.

You may qualify if:

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

You may not qualify if:

• \- Patients not treated with carboplatin previously

Sponsors & Collaborators

• Oslo University Hospital: lead
• Swedish Orphan Biovitrum: collaborator

MeSH Terms

Conditions

Ovarian Neoplasms; Vomiting

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erik Rokkones, PhD

  Head of Gyn. Onc. Department, Oslo University Hospital

  STUDY DIRECTOR

• Torbjørn Paulsen, PhD

  Oslo University hospital, Dept. Gyn. Oncology, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 23, 2022
• Study Start: March 7, 2016
• Primary Completion: May 20, 2019
• Study Completion: August 1, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: End of 2023
• Access Criteria: A description of the purpose of data sharing.