Intraperitoneal Bortezomib and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

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Brief Title

Intraperitoneal Bortezomib and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Official Title

A Phase I Pharmacokinetic Study of Intraperitoneal CTEP-Supplied Agent Bortezomib (PS-341, NSC 681239) and Carboplatin (NSC# 241240) in Patients With Persistent or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Brief Summary

      This phase I trial studies the side effects and best dose of intraperitoneal bortezomib when
      given together with intraperitoneal carboplatin in treating patients with ovarian epithelial
      cancer, fallopian tube cancer, or primary peritoneal cancer that is persistent or has come
      back. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed
      for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to
      stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,
      or by stopping them from spreading. Bortezomib may help carboplatin work better by making
      tumor cells more sensitive to the drug. Infusing bortezomib and carboplatin directly into the
      abdomen (intraperitoneal) may kill more tumor cells.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLTs) of
      intraperitoneal (IP) bortezomib (BTZ) when administered with intraperitoneal carboplatin in
      women with epithelial ovarian, fallopian tube, or primary peritoneal cancer that is
      persistent or recurrent and who have failed primary therapy and at least one second-line
      therapy.

      II. To examine the safety of administering BTZ in combination with carboplatin by the IP
      route.

      SECONDARY OBJECTIVES:

      I. To estimate objective tumor response rate as determined by Response Evaluation Criteria in
      Solid Tumors (RECIST) 1.1 criteria.

      II. To determine the pharmacokinetic profile of BTZ and carboplatin when administered
      intraperitoneally once every 21 days.

      III. To characterize the frequency of carboplatin hypersensitivity reactions (HSR) when
      administered as an intraperitoneal infusion in the context of recurrent ovarian cancer.

      OUTLINE: This is a dose-escalation study of bortezomib.

      Patients receive bortezomib intraperitoneally (IP) and carboplatin IP on day 1. Treatment
      repeats every 21 days for 6 courses in the absence of disease progression or unacceptable
      toxicity.

      After completion of study treatment, patients are followed up every 3 months for 1 year.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Dose-limiting toxicities defined by drug-related adverse events which occur in association with the first course of treatment as evaluated by the NCI CTCAE version 4 unless clearly unrelated to study drugs (e.g., disease progression)

Secondary Outcome

 Objective tumor response (complete and partial response)

Condition

Fallopian Tube Clear Cell Adenocarcinoma

Intervention

Bortezomib

Study Arms / Comparison Groups

 Treatment (bortezomib, carboplatin)
Description:  Patients receive bortezomib IP and carboplatin IP on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

33

Start Date

April 5, 2010

Completion Date

January 27, 2018

Primary Completion Date

April 4, 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or
             primary peritoneal cancer; histologic documentation of the original primary tumor is
             required via the pathology report

               -  Patients with the following histologic epithelial cell types are eligible: serous
                  adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma,
                  undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial
                  carcinoma, transitional cell carcinoma, malignant Brenner's tumor, or
                  adenocarcinoma not otherwise specified (N.O.S)

          -  Patients must have either measurable disease or detectable disease:

               -  Measurable disease will be defined by Response Evaluation Criteria in Solid
                  Tumors (RECIST) 1.1; measureable disease is defined as at least one lesion that
                  can be accurately measured in at least one dimension (longest dimension to be
                  recorded); each lesion must be >= 10 mm when measured by computed tomography
                  (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam;
                  or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short
                  axis when measured by CT or MRI

               -  Detectable disease is defined in a patient as one who does not have measurable
                  disease but has at least one of the following conditions:

                    -  Baseline values of cancer antigen (CA)-125 at least twice the upper limit of
                       normal

                    -  Ascites and/or pleural effusion attributed to tumor

                    -  Solid and/or cystic abnormalities on radiographic imaging that do not meet
                       RECIST 1.1 definitions for target lesions

               -  In addition, patients are allowed to undergo surgical cytoreduction of relapsed
                  disease as proof of detectable disease at the discretion of their treating
                  physician; if performed to allow participation in this protocol, the operative
                  and pathology reports will be required for submission

          -  Patients must have a Gynecologic Oncology Group (GOG) performance status 0, 1, or 2

          -  Recovery from effects of recent surgery, radiotherapy, or chemotherapy

               -  Patients should be free of active infection requiring antibiotics (with the
                  exception of uncomplicated urinary tract infection [UTI])

               -  Any hormonal therapy directed at the malignant tumor must be discontinued at
                  least one week prior to registration; continuation of hormone replacement therapy
                  is permitted

               -  Any other prior therapy directed at the malignant tumor, including biological and
                  immunologic agents, must be discontinued at least three weeks prior to
                  registration

          -  Patients must have had one prior platinum-based chemotherapeutic regimen for
             management of primary disease containing carboplatin, cisplatin, or another
             organoplatinum compound; this initial treatment may have included non-cytotoxic
             therapy, intraperitoneal therapy, consolidation, or extended therapy administered
             after surgical or non-surgical assessment

               -  Patients are required to receive, one additional cytotoxic regimen for management
                  of recurrent or persistent disease

               -  Patients are allowed to receive, but are not required to receive, two additional
                  cytotoxic regimens for management of recurrent or persistent disease (maximum
                  number of prior cytotoxic regimens including primary therapy is 4); patients are
                  allowed to receive, but are not required to receive, biologic (non-cytotoxic)
                  therapy either alone or as part of the cytotoxic regimens for management of
                  recurrent or persistent disease

          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to the
             National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) version 4 grade 1

          -  Platelets greater than or equal to 100,000/mcl

          -  Creatinine less than or equal to institutional upper limit of normal (ULN)

          -  Bilirubin less than or equal to 1.5 x ULN (per the NCI CTCAE version 4 grade 1)

          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less
             than or equal to 3 x ULN (per the active version of the NCI CTCAE grade 1)

          -  Alkaline phosphatase less than or equal to 2.5 x ULN (per the NCI CTCAE version 4
             grade 1)

          -  Neuropathy (sensory and motor) less than or equal to the NCI CTCAE version 4 grade 1

          -  Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN
             (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of
             therapeutic warfarin)

          -  Partial thromboplastin time (PTT) =< 1.5 x ULN (heparin, low molecular weight heparin,
             or alternative anticoagulants are acceptable)

          -  Patients who have met the pre-entry requirements

          -  An approved informed consent and authorization permitting release of personal health
             information must be signed by the patient or guardian

          -  Patients of childbearing potential must have a negative serum pregnancy test prior to
             the study entry and be practicing an effective form of contraception

          -  Patients in this trial may receive ovarian estrogen +/- progestin replacement therapy
             as indicated at the lowest effective dose(s) for control of menopausal symptoms at any
             time, but not progestins for management of anorexia while on protocol directed therapy
             or prior to disease progression

        Exclusion Criteria:

          -  Patients who have had prior therapy with bortezomib

          -  Patient with a history of other invasive malignancies, with the exceptions of
             non-melanoma skin cancer and localized breast cancer, are excluded if there is any
             evidence of other malignancy being present within the last five years; patients are
             also excluded if their previous cancer treatment contraindicates this protocol therapy

          -  Patients who have received prior radiotherapy to any portion of the abdominal cavity
             or pelvis OTHER THAN for the treatment of ovarian cancer are excluded; prior radiation
             for localized cancer of the breast, head and neck, or skin is permitted, provided that
             it was completed more than three years prior to registration, and the patient remains
             free of recurrent or metastatic disease

          -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER
             THAN for the treatment of ovarian cancer are excluded

               -  Patients may have received prior adjuvant chemotherapy for localized breast
                  cancer, provided that it was completed more than three years prior to
                  registration, and that the patient remains free of recurrent or metastatic
                  disease

          -  Patients with known brain metastases are excluded

          -  History of allergic reactions attributed to carboplatin or compounds of similar
             chemical or biologic composition to bortezomib including boron or mannitol

          -  Patients with synchronous primary endometrial cancer, or a past history of primary
             endometrial cancer, are excluded, unless all of the following conditions are met:
             stage not greater than I-B; no more than superficial myometrial invasion, without
             vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary
             serous, clear cell or other International Federation of Gynecology and Obstetrics
             (FIGO) grade 3 lesions

          -  Patients with a history of prior myocardial infarction in the last 12 months or
             patients with new electrocardiographic evidence of acute ischemia or new conduction
             abnormalities are ineligible

          -  Uncontrolled concurrent illness including but not limited to ongoing or active
             infection that requires parenteral antibiotics, acute hepatitis, symptomatic
             congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric
             illness/social situations that would limit compliance with study requirements

          -  Patients with insulin-dependent diabetes will be excluded

          -  Concomitant medications known to inhibit or induce cytochrome P450, family 3,
             subfamily A, polypeptide 4 (3A4) are to be avoided
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Don Dizon, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01074411

Organization ID

NCI-2011-02014

Secondary IDs

NCI-2011-02014

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Collaborators

 NRG Oncology

Study Sponsor

Don Dizon, Principal Investigator, NRG Oncology


Verification Date

August 2019