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Reprab Study: PLD + Trabectedin Rechallenge (MITO36)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04887961
Recruitment Status : Recruiting
First Posted : May 14, 2021
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
SCAMBIA GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary:
RECHALLENGE WITH PEGYLATED LIPOSOMAL DOXORUBICIN ADDED TO TRABECTEDIN IN RECURRENT OVARIAN CANCER: A MULTICENTER, PROSPECTIVE TRIAL

Condition or disease Intervention/treatment Phase
Relapsed Ovarian Cancer Drug: PLD and Trabectedin rechallenge Phase 2

Detailed Description:
To demonstrate that rechallenge with pegylated liposomal doxorubicin (PLD) with the combination of trabectedin (Yondelis®) is active (objective response rate) in relapsed ovarian cancer patients who have already received pegylated liposomal doxorubicin and progress within 6-12 months after the end of last platinum or in fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective multicenter phase II study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rechallenge With PLD Added to Trabectedine in Recurrent Ovarian Cancer: a Multicenter Prospective Trial
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Trabectedin

Arm Intervention/treatment
Experimental: Single Arm
PLD 30 mg/mq 1 h iv + Trabectedin 1.1 mg/mq 3 h iv d1q21 up to 6 cycles or PD.
Drug: PLD and Trabectedin rechallenge
Platinum partially sensitive patients i.e. patients who recur with a platinum free interval between 6 and 12 months, who have previously received pegylated liposomal doxorubicin and are suitable for rechallenge with pegylated liposomal doxorubicin (PLD) with the combination of trabectedin (Yondelis®) and relapsed ovarian cancer fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 30 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Female aged ≥ 18 years.
  • Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
  • Platinum partially sensitive patients or fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments, who have previously received pegylated liposomal doxorubicin (carboplatin- pegylated liposomal doxorubicin or pegylated liposomal doxorubicin alone).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0- 1.
  • Subject has radiographically-documented measurable disease, as per RECIST 1.1 at study entry (CA-125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression).
  • Be able to receive IV dexamethasone or an equivalent IV corticosteroid.
  • Have all of the following:

hemoglobin ≥9 g/dL (without transfusion in the prior 7 days). Subjects may be enrolled into the study while receiving recombinant erythropoietin provide they have received recombinant erythropoietin for at least 4 weeks. before the first dose of study drug.

albumin >25 g/L absolute neutrophil count (ANC) >1,500/μL platelet count >100,000/μL (without transfusion in the prior 7 days) either a serum creatinine <=1.5 mg/dL or a calculated glomerular filtration rate >60 mL/min/1.73 m2 (Cockcroft-Gault) CPK <2.5 x upper limit of normal (ULN) Have total bilirubin <xULN. If total bilirubin is > 1,5xULN, measure direct and indirect bilirubin to evaluate for Gilbert's syndrome (if direct bilirubin is within normal range, subject may be eligible).

Have alkaline phosphatase (ALP) 2.5xULN; if the ALP is >2.5xULN, then an ALP liver fraction or 5' nucleotidase must be <ULN (as reported in absolute units of measure).

Have AST and ALT 2.5xULN. Have LVEF by MUGA scan or 2D-ECHO within normal limits for the institution.

  • Patients must be in postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically
  • Adequate recovery from acute toxicity of any prior treatment

Exclusion criteria:

  • Non-epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)
  • Patients who did not respond to last platinum-based therapy or in whom last relapse occurred < 6 months from the last dose of platinum
  • Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases
  • Known hypersensitivity to any of the components of pegylated liposomal doxorubicin or TRABECTEDIN i.v. formulation
  • Previous treatment with Trabectedin
  • Known hypersensitivity to dexamethasone
  • Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy.
  • History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer
  • Myocardial failure within six months before enrolment, New York
  • Association (NYHA) Class II or worse heart failure, uncontrolled angina, severe uncontrolled ventricular arythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
  • Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential subjects who test positive for hepatitis B surface antigen or hepatitis C antibodies are allowed provided they do not have active disease requiring antiviral therapy). Also known history of liver carcinoma and cholangitis with abnormal liver functionality
  • Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
  • Known clinically relevant CNS metastases
  • Psychiatric disorder that prevents compliance with protocol
  • Patients with concurrent serious or uncontrolled infection
  • Patients in need of yellow fever vaccine while on study chemotherapy
  • Active infection
  • Breastfeeding women
  • Pregnant women
  • Any other unstable medical condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04887961


Contacts
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Contact: Giovanni Scambia, PI 0630153250 Giovanni.scambia@policlinicogemelli.it

Locations
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Italy
Fondazione Policlinico Gemelli IRCCS Recruiting
Roma, Italy, 00168
Contact: Claudia Marchetti, Dr    +390630151    claudia.marchetti@policlinicogemelli.it   
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Responsible Party: SCAMBIA GIOVANNI, Associate Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT04887961    
Other Study ID Numbers: MITO36
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by SCAMBIA GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
PLD
Trabectedine
Relapred ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents