Carboplatin-Paclitaxel-Bevacizumab vs Carbo-Pacli-Beva-Rucaparib vs Carbo-Pacli-Ruca, Selected According to HRD Status, in Patients With Advanced Ovarian, Primary Peritoneal and Fallopian Tube Cancer, Preceded by a Phase I Dose Escalation Study on Ruca-Beva Combination
NCT ID: NCT03462212
Last Updated: 2021-08-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE1/PHASE2
Total Enrollment
290 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-03-17
Study Completion Date
2025-03-01
Brief Summary
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This trial is a randomized, open-label Phase I-2 multi-center study designed to evaluate the effect of Carboplatin-Paclitaxel-Bevacizumab (in combination and maintenance) vs Carboplatin-Paclitaxel-Bevacizumab-Rucaparib (Rucaparib only in maintenance) vs Carboplatin-Paclitaxel-Rucaparib (Rucaparib only in maintenance) on progression-free survival in patients with advanced high grade ovarian cancer treated according to HRD status . The trial will test the hypothesis that Carboplatin-Paclitaxel-Bevacizumab-Rucaparib and the Carboplatin-Paclitaxel-Rucaparib arms will improve the progression-free survival in comparison to standard Carboplatin-Paclitaxel-Bevacizumab in HRD negative (HR proficient) patients and that Carboplatin-Paclitaxel-Bevacizumab-Rucaparib will improve PFS with respect to Carboplatin-Paclitaxel-Rucaparib in HRD positive patients. The randomized phase of the study will be preceded by a single arm Phase I study which will be conducted only in the National Cancer Institute of Milan, aiming at evaluating the MTD of the combination Rucaparib-Bevacizumab. Once the MTD has been reached, the randomized study will start.
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PHASE4
Detailed Description
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Phase I study design:
This is a single-centre, Phase I, open-label, dose-escalation study to evaluate the safety and tolerability of bevacizumab-rucaparib combination and determine the MTD in patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The dose of bevacizumab is fixed in cohort 1, 2 and 3 of the study at 15mg/kg, q 3 weekly.
The dose of rucaparib is evaluated in three cohorts (400 mg BID; 500 mg BID; 600 mg BID).
This trial will enroll at least 3 patients in cohort 1 with dose escalation to rucaparib 500 mg from cohort 1 to 2. Cohort 2 will enroll at least 3 patients with dose escalation to rucaparib 600 mg from cohort 2 to 3.
The standard 3+3 design will be used. Patients will be enrolled in cohort of 3 patients, if no DLT event will be reported among the first 3 patients, a second cohort will be enrolled at the upper dose level. If 1 DLT event is registered in the first cohort, other 3 patients will be enrolled at the same dose.
Phase II study design:
Eligible patients with histological documented high grade Stage IIIB-IIIC-IV ovarian cancer (regardless of residual tumor) will be randomized 1:1:1 according to a molecular driven treatment.
HRD positive patients:
* ARM B: Carboplatin AUC 5 + Paclitaxel 175 mg/m2 q 21 for 6 cycles followed by Rucaparib 600 mg BID q 28 for 24 cycles as maintenance
* ARM C: Carboplatin AUC 5+ Paclitaxel 175 mg/m2 q 21 + Bevacizumab 15 mg/kg for 6 cycles followed by Bevacizumab 15 mg/kg q 21 days for 16 cycles (Bevacizumab will start from Cycle 2) + Rucaparib 500 mg part BID q 28 for 24 cycles as maintenance
HRD negative patients:
* ARM A: Carboplatin AUC 5 + Paclitaxel 175 mg/m2 q 21 + Bevacizumab 15 mg/kg for 6 cycles followed by Bevacizumab 15 mg/kg q 21 for 16 cycles (Bevacizumab will start from Cycle 2)
* ARM B: Carboplatin AUC 5 + Paclitaxel 175 mg/m2 q 21 for 6 cycles followed by Rucaparib 600 mg BID q 28 for 24 cycles as maintenance
Stratification factors are:
* Residual tumor at primary surgery (RT=0 vs RT\> 0)
* Neoadiuvant chemotherapy (Yes or not)
This is a single-centre, Phase I, open-label, dose-escalation study to evaluate the safety and tolerability of bevacizumab-rucaparib combination and determine the MTD in patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The dose of bevacizumab is fixed in cohort 1, 2 and 3 of the study at 15mg/kg, q 3 weekly.
The dose of rucaparib is evaluated in three cohorts (400 mg BID; 500 mg BID; 600 mg BID).
This trial will enroll at least 3 patients in cohort 1 with dose escalation to rucaparib 500 mg from cohort 1 to 2. Cohort 2 will enroll at least 3 patients with dose escalation to rucaparib 600 mg from cohort 2 to 3.
The standard 3+3 design will be used. Patients will be enrolled in cohort of 3 patients, if no DLT event will be reported among the first 3 patients, a second cohort will be enrolled at the upper dose level. If 1 DLT event is registered in the first cohort, other 3 patients will be enrolled at the same dose.
Phase II study design:
Eligible patients with histological documented high grade Stage IIIB-IIIC-IV ovarian cancer (regardless of residual tumor) will be randomized 1:1:1 according to a molecular driven treatment.
HRD positive patients:
* ARM B: Carboplatin AUC 5 + Paclitaxel 175 mg/m2 q 21 for 6 cycles followed by Rucaparib 600 mg BID q 28 for 24 cycles as maintenance
* ARM C: Carboplatin AUC 5+ Paclitaxel 175 mg/m2 q 21 + Bevacizumab 15 mg/kg for 6 cycles followed by Bevacizumab 15 mg/kg q 21 days for 16 cycles (Bevacizumab will start from Cycle 2) + Rucaparib 500 mg part BID q 28 for 24 cycles as maintenance
HRD negative patients:
* ARM A: Carboplatin AUC 5 + Paclitaxel 175 mg/m2 q 21 + Bevacizumab 15 mg/kg for 6 cycles followed by Bevacizumab 15 mg/kg q 21 for 16 cycles (Bevacizumab will start from Cycle 2)
* ARM B: Carboplatin AUC 5 + Paclitaxel 175 mg/m2 q 21 for 6 cycles followed by Rucaparib 600 mg BID q 28 for 24 cycles as maintenance
Stratification factors are:
* Residual tumor at primary surgery (RT=0 vs RT\> 0)
* Neoadiuvant chemotherapy (Yes or not)
Conditions
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Advanced (Stage IIIB-C-IV) Ovarian, Primary Peritoneal and Fallopian Tube Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Standard treatment
Carboplatin AUC 5 + Paclitaxel 175 mg/mq d 1 q 21 for 6 cycles + Bevacizumab 15 mg/kg d 1 q 21 days for 22 cycles (in combination and maintenance)
Group Type
OTHER
Carboplatin
Intervention Type
DRUG
chemotherapy medication
Paclitaxel
Intervention Type
DRUG
chemotherapy medication
Bevacizumab
Intervention Type
DRUG
Angiogenesis inhibitor
Carboplatin + Paclitaxel + Bevacizumab + Rucaparib
Carboplatin AUC 5 + Paclitaxel 175 mg/mq d1 q 21 days for 6 cycles + Bevacizumab 15 mg/kg d1 q 21 for 22 cycles (in combination and maintenance) + Rucaparib at the dose defined by the Phase I study continuously for 2 years (Rucaparib only in maintenance)
Group Type
EXPERIMENTAL
Carboplatin
Intervention Type
DRUG
chemotherapy medication
Paclitaxel
Intervention Type
DRUG
chemotherapy medication
Bevacizumab
Intervention Type
DRUG
Angiogenesis inhibitor
Rucaparib
Intervention Type
DRUG
PARP inhibitor
Carboplatin + Paclitaxel + Rucaparib
Carboplatin AUC 5 + Paclitaxel 175 mg/mq d1 q 21 days for 6 cycles + Rucaparib 600 mg BID continuously for 2 years (Rucaparib only as maintenance).
Group Type
EXPERIMENTAL
Carboplatin
Intervention Type
DRUG
chemotherapy medication
Paclitaxel
Intervention Type
DRUG
chemotherapy medication
Rucaparib
Intervention Type
DRUG
PARP inhibitor
Interventions
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Carboplatin
chemotherapy medication
Intervention Type
DRUG
Paclitaxel
chemotherapy medication
Intervention Type
DRUG
Bevacizumab
Angiogenesis inhibitor
Intervention Type
DRUG
Rucaparib
PARP inhibitor
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Women aged \>=18 years at the time of study inclusion;
2. Patients with newly diagnosed, histologically confirmed, high grade serous, high grade endometrioid, FIGO stage IIIB-C-IV epithelial ovarian cancer, primary peritoneal cancer and / or Fallopian-tube cancer. Patients with mixed histology (carcinosarcoma) are eligible providing that high grade tumor represent more than 50% of the total histology.
Stage III patients should have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery;
3. Archival tumor tissue available. At progression fresh biopsy is optional for patients willing to submit ;
4. ECOG Performance Status of 0-1;
5. Measurable and not measurable disease;
6. Adequate renal and hepatic function, defined as:
* Total serum bilirubin ≤ 1.5 institutional ULN unless patient has Gilbert's syndrome in which case total serum bilirubin must be \<2 ULN for the institution AST and/or ALT ≤ 2.5 x ULN for the institution. (or ≤ 5 x ULN if liver metastases are present);
* Alkaline phosphatase \< 1.5 x ULN for the institution (if \> 1.5 x ULN, then alkaline phosphatase liver fraction must be \< 1.5 ULN)
* Serum creatinine ≤ 1.5 x ULN for the institution (or calculated creatinine clearance ≥ 45 mL/min/1.73 m2);
7. Adequate bone marrow function, defined as:
* Total leukocytes 2.5 x 109/L;
* ANC 1.5 x 109/L;
* Platelet count 100 x 109/L;
8. Able to understand and give written informed consent;
9. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
2. Patients with newly diagnosed, histologically confirmed, high grade serous, high grade endometrioid, FIGO stage IIIB-C-IV epithelial ovarian cancer, primary peritoneal cancer and / or Fallopian-tube cancer. Patients with mixed histology (carcinosarcoma) are eligible providing that high grade tumor represent more than 50% of the total histology.
Stage III patients should have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery;
3. Archival tumor tissue available. At progression fresh biopsy is optional for patients willing to submit ;
4. ECOG Performance Status of 0-1;
5. Measurable and not measurable disease;
6. Adequate renal and hepatic function, defined as:
* Total serum bilirubin ≤ 1.5 institutional ULN unless patient has Gilbert's syndrome in which case total serum bilirubin must be \<2 ULN for the institution AST and/or ALT ≤ 2.5 x ULN for the institution. (or ≤ 5 x ULN if liver metastases are present);
* Alkaline phosphatase \< 1.5 x ULN for the institution (if \> 1.5 x ULN, then alkaline phosphatase liver fraction must be \< 1.5 ULN)
* Serum creatinine ≤ 1.5 x ULN for the institution (or calculated creatinine clearance ≥ 45 mL/min/1.73 m2);
7. Adequate bone marrow function, defined as:
* Total leukocytes 2.5 x 109/L;
* ANC 1.5 x 109/L;
* Platelet count 100 x 109/L;
8. Able to understand and give written informed consent;
9. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Exclusion Criteria
1. Women who are pregnant or lactating;
2. Presence of brain or other central nervous system metastases, not adequately controlled by treatment;
3. Prior Anticancer treatment;
4. Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 3 weeks prior to randomization;
5. Another primary malignancy except for:
1. Curatively treated non-melanoma skin cancer;
2. Breast cancer treated curatively ≥5 years ago, or other solid tumor treated curatively ≥5 years ago, without evidence of recurrence;
3. Synchronous endometrioid endometrial cancer (except for Stage 1A G1/G2);
6. Known active HIV, hepatitis B or C infection;
7. Concurrent treatment with immunosuppressive or investigational agents;
8. History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular accident (CVA) / stroke or transient ischemic attack (TIA) or subarachnoid haemorrhage within \_6 months prior to the first study treatment);
9. Clinically significant (i.e. active) cardiovascular disease, including:
* Myocardial infarction or unstable angina within \_6 months prior to the first study treatment;
* New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF);
* Serious cardiac arrhythmia requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia);
* Peripheral vascular disease \> grade 3 (i.e.symptomatic and interfering with activities of daily living requiring repair or revision);
10. Serious active infection requiring i.v. antibiotics at enrolment;
11. Known hypersensitivity to any of the study drugs or excipients (including cremophor and hamster Ovary cell products);
12. Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications;
13. Prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with absorption of study drug;
14. Received administration of strong CYP1A2 or CYP3A4 inhibitors ≤7 days prior to first dose of Rucaparib or have on-going requirements for these medications.
2. Presence of brain or other central nervous system metastases, not adequately controlled by treatment;
3. Prior Anticancer treatment;
4. Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 3 weeks prior to randomization;
5. Another primary malignancy except for:
1. Curatively treated non-melanoma skin cancer;
2. Breast cancer treated curatively ≥5 years ago, or other solid tumor treated curatively ≥5 years ago, without evidence of recurrence;
3. Synchronous endometrioid endometrial cancer (except for Stage 1A G1/G2);
6. Known active HIV, hepatitis B or C infection;
7. Concurrent treatment with immunosuppressive or investigational agents;
8. History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular accident (CVA) / stroke or transient ischemic attack (TIA) or subarachnoid haemorrhage within \_6 months prior to the first study treatment);
9. Clinically significant (i.e. active) cardiovascular disease, including:
* Myocardial infarction or unstable angina within \_6 months prior to the first study treatment;
* New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF);
* Serious cardiac arrhythmia requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia);
* Peripheral vascular disease \> grade 3 (i.e.symptomatic and interfering with activities of daily living requiring repair or revision);
10. Serious active infection requiring i.v. antibiotics at enrolment;
11. Known hypersensitivity to any of the study drugs or excipients (including cremophor and hamster Ovary cell products);
12. Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications;
13. Prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with absorption of study drug;
14. Received administration of strong CYP1A2 or CYP3A4 inhibitors ≤7 days prior to first dose of Rucaparib or have on-going requirements for these medications.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Istituto Di Ricerche Farmacologiche Mario Negri
OTHER
Sponsor Role
collaborator
Foundation Medicine
INDUSTRY
Sponsor Role
collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Domenica Lorusso, Prof.
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
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Ospedale Mater Salutis
Legnago, , Italy
Site Status
RECRUITING
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Site Status
RECRUITING
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, , Italy
Site Status
RECRUITING
Azienda Ospedaliera di Perugia
Perugia, , Italy
Site Status
RECRUITING
Nuovo Ospedale degli Infermi
Ponderano, , Italy
Site Status
RECRUITING
Fondazione Policlinico Universitario A.Gemelli IRCCS
Rome, , Italy
Site Status
RECRUITING
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
Turin, , Italy
Site Status
RECRUITING
Countries
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Italy
Central Contacts
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References
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De Bono JS, Mina LA, Gonzalez M, Curtin NJ, Wang E, Henshaw JW, et al. First-in-human trial of novel oral PARP inhibitor BMN 673 in patients with solid tumors. J Clin Oncol. 2013;31(suppl):2580.
Reference Type
BACKGROUND
Iain A. McNeish, Amit M. Oza, Robert L. Coleman, et al. Results of ARIEL2: A Phase II trial to prospectively identify ovarian cancer patients likely to respond to rucaparib using tumor genetic analysis. J Clin Oncol 33, 2015 (suppl; abstr 5508)
Reference Type
BACKGROUND
Gourley, C. McCavigan, A Perren, T et al Molecular subgroup of high-grade serous ovarian cancer (HGSOC) as a predictor of outcome following bevacizumab. Abstract 5502 ASC0 2014
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BACKGROUND
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.
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Chan JK, Cheung MK, Husain A, Teng NN, West D, Whittemore AS, Berek JS, Osann K. Patterns and progress in ovarian cancer over 14 years. Obstet Gynecol. 2006 Sep;108(3 Pt 1):521-8. doi: 10.1097/01.AOG.0000231680.58221.a7.
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RESULT
Engel J, Eckel R, Schubert-Fritschle G, Kerr J, Kuhn W, Diebold J, Kimmig R, Rehbock J, Holzel D. Moderate progress for ovarian cancer in the last 20 years: prolongation of survival, but no improvement in the cure rate. Eur J Cancer. 2002 Dec;38(18):2435-45. doi: 10.1016/s0959-8049(02)00495-1.
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RESULT
Harries M, Gore M. Part I: chemotherapy for epithelial ovarian cancer-treatment at first diagnosis. Lancet Oncol. 2002 Sep;3(9):529-36. doi: 10.1016/s1470-2045(02)00846-x.
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RESULT
International Collaborative Ovarian Neoplasm Group. Paclitaxel plus carboplatin versus standard chemotherapy with either single-agent carboplatin or cyclophosphamide, doxorubicin, and cisplatin in women with ovarian cancer: the ICON3 randomised trial. Lancet. 2002 Aug 17;360(9332):505-15. doi: 10.1016/S0140-6736(02)09738-6.
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RESULT
Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.
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RESULT
McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, Clarke-Pearson DL, Davidson M. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med. 1996 Jan 4;334(1):1-6. doi: 10.1056/NEJM199601043340101.
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RESULT
Piccart MJ, Bertelsen K, James K, Cassidy J, Mangioni C, Simonsen E, Stuart G, Kaye S, Vergote I, Blom R, Grimshaw R, Atkinson RJ, Swenerton KD, Trope C, Nardi M, Kaern J, Tumolo S, Timmers P, Roy JA, Lhoas F, Lindvall B, Bacon M, Birt A, Andersen JE, Zee B, Paul J, Baron B, Pecorelli S. Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results. J Natl Cancer Inst. 2000 May 3;92(9):699-708. doi: 10.1093/jnci/92.9.699.
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RESULT
Spannuth WA, Sood AK, Coleman RL. Angiogenesis as a strategic target for ovarian cancer therapy. Nat Clin Pract Oncol. 2008 Apr;5(4):194-204. doi: 10.1038/ncponc1051. Epub 2008 Feb 12.
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RESULT
du Bois A, Quinn M, Thigpen T, Vermorken J, Avall-Lundqvist E, Bookman M, Bowtell D, Brady M, Casado A, Cervantes A, Eisenhauer E, Friedlaender M, Fujiwara K, Grenman S, Guastalla JP, Harper P, Hogberg T, Kaye S, Kitchener H, Kristensen G, Mannel R, Meier W, Miller B, Neijt JP, Oza A, Ozols R, Parmar M, Pecorelli S, Pfisterer J, Poveda A, Provencher D, Pujade-Lauraine E, Randall M, Rochon J, Rustin G, Sagae S, Stehman F, Stuart G, Trimble E, Vasey P, Vergote I, Verheijen R, Wagner U; Gynecologic Cancer Intergroup; AGO-OVAR; ANZGOG; EORTC; GEICO; GINECO; GOG; JGOG; MRC/NCRI; NCIC-CTG; NCI-US; NSGO; RTOG; SGCTG; IGCS; Organizational team of the two prior International OCCC. 2004 consensus statements on the management of ovarian cancer: final document of the 3rd International Gynecologic Cancer Intergroup Ovarian Cancer Consensus Conference (GCIG OCCC 2004). Ann Oncol. 2005;16 Suppl 8:viii7-viii12. doi: 10.1093/annonc/mdi961. No abstract available.
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RESULT
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RESULT
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RESULT
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RESULT
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RESULT
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RESULT
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Lorusso D, Maltese G, Sabatucci I, Cresta S, Matteo C, Ceruti T, D'Incalci M, Zucchetti M, Raspagliesi F, Sonetto C, Sinno V, Ronzulli D, Giolitto S, de Braud F. Phase I Study of Rucaparib in Combination with Bevacizumab in Ovarian Cancer Patients: Maximum Tolerated Dose and Pharmacokinetic Profile. Target Oncol. 2021 Jan;16(1):59-68. doi: 10.1007/s11523-020-00780-4. Epub 2020 Dec 28.
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DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3329
Identifier Type: -
Identifier Source: org_study_id
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