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| Name | Class |
|---|---|
| PharmaMar | INDUSTRY |
| Hoffmann-La Roche | INDUSTRY |
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This study is aimed at assessing the efficacy and the safety of the combination of bevacizumab and trabectedin with or without carboplatin in adult women with epithelial ovarian cancer at first recurrence occurred 6-12 months after the end of the last (first or second) platinum-containing regimen. According to the Bryant and Day design the primary endpoints will be the proportion of progression-free patients at 6 months for the efficacy, and the proportion of patients with severe toxicity for the safety at the same time-point.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bevacizumab and trabectedin | Experimental | Arm A: bevacizumab (15 mg/kg) given as 1 hour infusion will be followed by trabectedin (1.1 mg/sqm) 3 hour iv infusion; to be repeated every 21 days until progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients |
|
| bevacizumab, trabectedin and carboplatin | Experimental | Arm B: cycle 1-6, bevacizumab given as 1 hour infusion will be followed by carboplatin area under curve 4 (AUC 4) and trabectedin 3 hour iv infusion. Cycle 7- end of treatment, bevacizumab given as 1 hour infusion will be followed by trabectedin 3 hour iv infusion. Patient enrolled in arm B will receive (cycle 1-6): trabectedin 0.8 mg/m2 ,carboplatin AUC 4 day 1 every 28 days and bevacizumab 10 mg/kg iv on day 1 and day 15. From cycle 7 to disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients will receive bevacizumab 15 mg/kg iv and trabectedin 1.1 mg/m2 day 1 every 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab and trabectedin | Drug | Arm A: bevacizumab (15 mg/kg) given as 1 hour infusion will be followed by trabectedin (1.1 mg/sqm) 3 hour iv infusion; to be repeated every 21 days until progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival at 6 months (PFS-6) | The PFS-6, defined as the percentage of patients who are alive and progression free at 6 months after the randomization. | from randomization up to 6 months |
| Proportion of patients with severe toxicity within 6 months from randomization. | The following conditions will be considered as severe toxicity:
| from randomization up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Defined for each patient as the time from the date of randomization to the date of first progression, second primary malignancy or death for any cause, whichever comes first. Subjects not progressed or died at the time of the analysis will be censored at the last disease assessment date. | from randomization up to 30 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicoletta Colombo, Medical D | IRCCS Istituto Europeo di Oncologia di Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Spedali Civili di Brescia | Brescia | Italy | ||||
| Istituto Europeo di Oncologia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31537908 | Result | Colombo N, Zaccarelli E, Baldoni A, Frezzini S, Scambia G, Palluzzi E, Tognon G, Lissoni AA, Rubino D, Ferrero A, Farina G, Negri E, Pesenti Gritti A, Galli F, Biagioli E, Rulli E, Poli D, Gerardi C, Torri V, Fossati R, D'Incalci M. Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer. Br J Cancer. 2019 Oct;121(9):744-750. doi: 10.1038/s41416-019-0584-5. Epub 2019 Sep 20. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077606 | Trabectedin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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This is a multicentre, randomized, non-comparative phase II study aimed at assessing efficacy and safety of two regimens according to a Bryant and Day two-stage design
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|
|
| bevacizumab, trabectedin and carboplatin | Drug | Arm B: cycle 1- 6, bevacizumab given as 1 hour infusion will be followed by carboplatin AUC 4 and trabectedin 3 hour iv infusion. Cycle 7- end of treatment, bevacizumab given as 1 hour infusion will be followed by trabectedin 3 hour iv infusion. Patient enrolled in arm B will receive (cycle 1-6): trabectedin 0.8 mg/m2 ,carboplatin AUC 4 day 1 every 28 days and bevacizumab 10 mg/kg iv on day 1 and day 15. From cycle 7 to disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients will receive bevacizumab 15 mg/kg iv and trabectedin 1.1 mg/m2 day 1 every 21 days |
|
|
| Overall survival at 12 months (OS-12) | Defined as the percentage of patients who are alive at 12 months after the randomization. | one year |
| Clinical Benefit (CB) | clinical benefit, defined as the percentage of patients who are judged by the Investigators to have a complete response (CR), or partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, version 1.1 after 12 weeks from the date of randomization. | from randomization up to 30 months |
| Incidence of Adverse Events (AEs) | Incidence of AEs, according to NCI-CTCAE, version 4.0 | from randomization up to 30 months |
| Maximum toxicity grade | Maximum toxicity grade experienced by each patient for each specific toxicity | from randomization up to 30 months |
| Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity | Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity during the study | from randomization up to 30 months |
| Patients with at least a Serious Adverse Drug Reaction (SADR) | Patients with at least a SADR during the study | from randomization up to 30 months |
| Patients with at least a Suspect Unexpected Serious Adverse Reaction (SUSAR). | Patients with at least a suspect unexpected serious adverse reaction during the study | from randomization up to 30 months |
| Percentage of patients with dose and/or time modifications | Percentage of patients with dose and/or time modifications of the study drugs | from randomization up to 30 months |
| Percentage of premature withdrawals | Percentage of premature withdrawals of the enrolled patients | from randomization up to 30 months |
| Patients with at least a Serious Adverse Event (SAE) | Patients with at least a SAE during the study | from randomization up to 30 months |
| Nature of AEs | Nature of AEs, according to NCI-CTCAE, version 4.0 | from randomization up to 30 months |
| Severity of AEs | Severity of AEs, according to NCI-CTCAE, version 4.0 | from randomization up to 30 months |
| Seriousness of AEs | Seriousness of AEs according to NCI-CTCAE, version 4.0 | from randomization up to 30 months |
| Milan |
| Italy |
| AO Fatebenefratelli e Oftalmico | Milan | Italy |
| Azienda Ospedaliera S. Gerardo | Monza | Italy |
| Istituto Oncologico Veneto | Padova | Italy |
| Policlinico Universitario Agostino Gemelli di Roma | Roma | Italy |
| Mauriziano Hospital | Torino | Italy |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004149 | Dioxoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |