Irinotecan Liposome and Bevacizumab for the Treatment of Platinum Resistant, Recurrent, or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT04753216 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: NU 20G02STU00213582P30CA060553NCI-2021-00765
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial investigates the effect of irinotecan liposome and bevacizumab in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that shows less response to platinum therapy (platinum resistant), has come back (recurrent), or does not respond to treatment (refractory). Irinotecan liposome may help block the formation of growths that may become cancer. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving irinotecan liposome and bevacizumab may kill more cancer cells.

Conditions

Platinum-Resistant Fallopian Tube Carcinoma; Platinum-Resistant Ovarian Carcinoma; Platinum-Resistant Primary Peritoneal Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Refractory Fallopian Tube Carcinoma; Refractory Ovarian Carcinoma; Refractory Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Defined as the proportion of treated subjects who experience an objective response, confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Complete Response (CR) = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD) = Neither sufficient shrinkage to qualify

  Up to 5 months

Secondary Outcomes (8)

• Overall Best Response

  Approximately 29 Weeks

• Clinical Benefit Rate (CBR)

  Approximately 29 Weeks

• Duration of Response (DOR)

  Approximately 29 Weeks

• Duration of Stable Disease

  Approximately 29 Weeks

• Time to Response (TTR)

  Approximately 29 Weeks

Study Arms (1)

Treatment (bevacizumab, irinotecan sucrosofate)

EXPERIMENTAL

Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Biological: Bevacizumab; Drug: Irinotecan Sucrosofate

Interventions

Bevacizumab BIOLOGICAL

Given IV

Also known as: Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, Zirabev

Treatment (bevacizumab, irinotecan sucrosofate)

Irinotecan Sucrosofate DRUG

Given IV

Also known as: Irinotecan Liposome, MM-398, nal-IRI, Nanoliposomal Irinotecan, Nanoparticle Liposome Formulation of Irinotecan, Onivyde, PEP02

Treatment (bevacizumab, irinotecan sucrosofate)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
• NOTE: Subjects with carcinosarcoma histology and/or mixed epithelial histology are not eligible.
• Subjects must have recurrent, platinum resistant or refractory disease, defined as progression \< 6 months after completion of a platinum-based chemotherapy regimen or as persistent disease that remains after completion of a platinum-based therapy
• Subjects must have measurable disease as assessed by RECIST 1.1
• Subjects must have received at least 1 but no more than 3 prior platinum-based chemotherapy regimens
• Subjects must have adequately recovered (in the opinion of the treating investigator) from adverse events due to prior anti-cancer therapy, with the exceptions of any grade alopecia and =\< grade 2 peripheral neuropathy per NCI-CTCAE version 5.0
• Subjects must be age \>= 18 years
• Subjects must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Hemoglobin \>= 9.0 g/dL (within =\< 28 days prior to registration)
• White blood cell (WBC) count \>= 3.0 x 10\^9/L (within =\< 28 days prior to registration)
• Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (within =\< 28 days prior to registration)
• Platelet count \>= 75 x 10\^9/L (within =\< 28 days prior to registration)
• Serum total bilirubin =\< 1.5 x upper limit of normal (ULN) or direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 x ULN
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SPGT\]) =\< 2.5 x ULN or =\< 5.0 x ULN for subjects with liver metastases
• Serum albumin \>= 3.0 g/dL

You may not qualify if:

• Subjects must not have received any prior irinotecan-based therapies.
• Subjects must not have received more than 3 prior platinum-based chemotherapy regimens.
• Subjects must not have received more than 2 prior non-platinum, cytotoxic chemotherapy regimens.
• Subjects must not have received chemotherapy, immunotherapy, monoclonal antibody (mAb) therapy, hormonal therapy, or other targeted therapy within =\< 14 days prior to registration.
• Subjects must not have received investigational agents or investigational devices within =\< 14 days prior to registration.
• Subjects must not have received VEGF-targeting agents, including bevacizumab, within =\< 6 months prior to registration
• Subjects must not have received prior radiotherapy to the pelvis or abdomen within =\< 3 months prior to registration. Subjects must not have received prior radiotherapy to other areas within =\< 14 days prior to registration
• Subjects must not have undergone a surgical procedure or jaw-invasive dental procedure (including tooth extraction) within =\< 28 days prior to registration
• Subjects must not have a known history of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, irinotecan liposome, or any of their excipients
• Subjects must not have received hematologic growth factors and/or blood products (transfusions) within =\< 28 days prior to registration
• Subjects must not be taking any of the medications listed as prohibited medications and therapies. Subjects receiving any medications or substances that are known strong CYP3A4 inducers, known strong CYP3A4 inhibitors, and/or known strong UGT1A1 inhibitors are ineligible.
• Known strong CYP3A4 inducers must be discontinued at least 2 weeks prior to initiation of irinotecan liposome to be eligible.
• Strong CYP3A4 inducers include, but are not limited to, the following: phenytoin, phenobarbital, primidone, carbamazepine, rifampin, rifabutin and rifapentine.
• Known strong CYP3A4 and UGT1A1 inhibitors must be discontinued at least 1 week prior to initiation of irinotecan liposome to be eligible.
• Strong CYP3A4 inhibitors include, but are not limited to, the following: ketoconazole, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole. (Note: fosaprepitant is permitted).

Sponsors & Collaborators

• Northwestern University: lead
• Ipsen: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Bevacizumab; Immunoglobulin G; Disulfides; irinotecan sucrosofate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Isotypes; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals

Results Point of Contact

• Title: Daniela Matei, MD
• Organization: Northwestern University Feinberg School of Medicine

daniela.matei@northwestern.edu

312-472-4684

Study Officials

• Daniela E Matei, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniela Matei, MD

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 15, 2021
• Study Start: March 16, 2021
• Primary Completion: August 31, 2021
• Study Completion: October 25, 2021
• Last Updated: January 19, 2023
• Results First Posted: January 19, 2023

Record last verified: 2022-12

Locations

US (1)