Ovarian NeoplasmTvsCHNCT05512676
Trabectedin/Caelyx vs Cisplatin Hypersensitivity in Relapsed Ovarian Cancer Patients Allergic to Platinum
An observational study of Ovarian Neoplasm and Chemotherapeutic Toxicity, run by Oslo University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ovarian Neoplasm, Chemotherapeutic Toxicity, Chemotherapy Effect
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 7 Mar 2016to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Women with recurrent ovarian cancer and
- allergic reaction to carboplatin or
- other serious side effects to carboplatin
Who cannot join
- Patients not treated with carboplatin previously
About this study
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
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.
Read the detailed description
INTRODUCTION Trabectedin (Yondelis®) is a tetrahydroisoquinoline alkaloid that is produced synthetically. It acts by interfering with DNA transcription factors, DNA binding proteins, and DNA repair pathways. This results in cell cycle arrest and apoptosis. Trabectedin (T) probably causes DNA double-strand breaks. Trabectedin decreases the level of proangiogenic VEGF, CCL2, and interleucin-6 (IL-6) which indicate that trabectedin is cytotoxic with immune regulatory effects (1).
Since 2007 trabectedin mainly has been used in the treatment of soft tissue sarcomas (1). In meningioma trabectedin has been used in a murine model of ovarian cancer (2). A combined treatment of trabectedin and anti-PD1 antibody produces a synergic antitumor effect (3).
In a phase III international multicentre study the addition of trabectedin to pegylated liposomal doxyrubicin (PLD) (Caelyx) has shown to improve progression free survival and overall response rate compared to PLD alone in second-line treatment of recurrent ovarian cancer (ROC) (4). Trabectedin can replace platinum in clinical settings where there has been serious allergic reaction adverse effect from platinum (Carboplatin) (4). In many of these patients Carboplatin has been replaced by Cisplatin hypersensitivity regimen (CH). In patients with serious side effects to Cisplatin or other factors that impair the treatment of Cisplatin, trabectedin is a good alternative (4).
Trabectedin may also have a therapeutic role in patients with recurrent BRCA mutated ovarian cancer patients (5,6). When combined with PLD, trabectedin improves progression free survival (PFS) and objective response rate (ORR) in the second line-treatment of ROC. The combination led to manageable and non-cumulative overall toxicity with a fewer PLD-associated adverse events (7,8,9).
The majority of patients treated with trabectedin are given the combination with PDL and patients treated with cisplatin have the combination with paclitaxel.
In the present study the investigators will examine the role of trabectedin in combination with PLD and cisplatin in treating platinum sensitive ROC being allergic to carboplatin. The investigators will focus on adverse events and evaluate if these are tolerable for the patients and further evaluate the measurable treatment effect on the tumor burden.
Primary aims:
To investigate if trabectedin in combination with pegylated liposomal doxyrubicin (PLD) is applicable to replace desensitising cisplatin ROC treatment.
Secondary aims:
- Effect on tumor burden (CT by RISK criteria, vaginal ultrasound, CA125).
- Level of adverse effects.
- To calculate the PFS of the two cohorts (trabectedin and cisplatin).
- To calculate cancer specific survival (CSS) of the two cohorts (trabectedin and cisplatin) MATERIAL AND METHODS A description of the indication of treatment and follow-up after treatment with trabectedin in combination with PLD or cisplatin at the Oslo University Hospital (OUS), Department of gynecologic cancer. This study is retrospective and prospective in design. Totally 20 patients treated with trabectedin in combination with PLD and 20 patients with cisplatin will be included in the study.
Platinum sensitive tumors are defined as tumors recurring 6 months or more after previouis platinum treatment. In the study the investigators will mainly include patients having allergic reactions to carboplatin.
- 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
- Medical subject headings
- Ovarian Neoplasms, Vomiting
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression Free Survival
Measured: 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.
Measured: 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)
Cancer Specific survival
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start7 Mar 2016
- Primary completion20 May 2019
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Orphan Biovitrum
- Responsible party
- Principal investigator, Torbjørn Paulsen, Oslo University Hospital
- Investigators
- Erik Rokkones, PhD, Study director, Head of Gyn. Onc. Department, Oslo University HospitalTorbjørn Paulsen, PhD, Principal investigator, Oslo University hospital, Dept. Gyn. Oncology, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512676
- Sponsor's protocol ID
- 2015/2167 REK sør-øst B
- Acronym
- TvsCH
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data are saved in individual Case Report Forms in pdf format. All data are encoded in SPSS. An anonymous SPSS File may be distributed on request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05512676
- Acronym / sponsor ID
- TvsCH / 2015/2167 REK sør-øst B
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Swedish Orphan Biovitrum
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
INTRODUCTION Trabectedin (Yondelis®) is a tetrahydroisoquinoline alkaloid that is produced synthetically. It acts by interfering with DNA transcription factors, DNA binding proteins, and DNA repair pathways. This results in cell cycle arrest and apoptosis. Trabectedin (T) probably causes DNA double-strand breaks. Trabectedin decreases the level of proangiogenic VEGF, CCL2, and interleucin-6 (IL-6) which indicate that trabectedin is cytotoxic with immune regulatory effects (1).
Since 2007 trabectedin mainly has been used in the treatment of soft tissue sarcomas (1). In meningioma trabectedin has been used in a murine model of ovarian cancer (2). A combined treatment of trabectedin and anti-PD1 antibody produces a synergic antitumor effect (3).
In a phase III international multicentre study the addition of trabectedin to pegylated liposomal doxyrubicin (PLD) (Caelyx) has shown to improve progression free survival and overall response rate compared to PLD alone in second-line treatment of recurrent ovarian cancer (ROC) (4). Trabectedin can replace platinum in clinical settings where there has been serious allergic reaction adverse effect from platinum (Carboplatin) (4). In many of these patients Carboplatin has been replaced by Cisplatin hypersensitivity regimen (CH). In patients with serious side effects to Cisplatin or other factors that impair the treatment of Cisplatin, trabectedin is a good alternative (4).
Trabectedin may also have a therapeutic role in patients with recurrent BRCA mutated ovarian cancer patients (5,6). When combined with PLD, trabectedin improves progression free survival (PFS) and objective response rate (ORR) in the second line-treatment of ROC. The combination led to manageable and non-cumulative overall toxicity with a fewer PLD-associated adverse events (7,8,9).
The majority of patients treated with trabectedin are given the combination with PDL and patients treated with cisplatin have the combination with paclitaxel.
In the present study the investigators will examine the role of trabectedin in combination with PLD and cisplatin in treating platinum sensitive ROC being allergic to carboplatin. The investigators will focus on adverse events and evaluate if these are tolerable for the patients and further evaluate the measurable treatment effect on the tumor burden.
Primary aims:
To investigate if trabectedin in combination with pegylated liposomal doxyrubicin (PLD) is applicable to replace desensitising cisplatin ROC treatment.
Secondary aims:
- Effect on tumor burden (CT by RISK criteria, vaginal ultrasound, CA125).
- Level of adverse effects.
- To calculate the PFS of the two cohorts (trabectedin and cisplatin).
- To calculate cancer specific survival (CSS) of the two cohorts (trabectedin and cisplatin) MATERIAL AND METHODS A description of the indication of treatment and follow-up after treatment with trabectedin in combination with PLD or cisplatin at the Oslo University Hospital (OUS), Department of gynecologic cancer. This study is retrospective and prospective in design. Totally 20 patients treated with trabectedin in combination with PLD and 20 patients with cisplatin will be included in the study.
Platinum sensitive tumors are defined as tumors recurring 6 months or more after previouis platinum treatment. In the study the investigators will mainly include patients having allergic reactions to carboplatin.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Women with recurrent ovarian cancer and
- allergic reaction to carboplatin or
- other serious side effects to carboplatin
Key exclusion criteria (1 listed)
- Patients not treated with carboplatin previously
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFS
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.
Progression Free Survival
Side effects
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..
Side effects of recurrent treatment from trabectedin/PLD and cisplatin hypersensitivity/paclitaxel.
2 secondary outcomes
Cancer Specific survival (CSS)
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: Yes. The data are saved in individual Case Report Forms in pdf format. All data are encoded in SPSS. An anonymous SPSS File may be distributed on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Rokkones, PhD study director
Head of Gyn. Onc. Department, Oslo University Hospital
Torbjørn Paulsen, PhD principal investigator
Oslo University hospital, Dept. Gyn. Oncology, Norway
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasm and Chemotherapeutic Toxicity, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.