Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed by Surgery or Gynecological Cancers

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Brief Title

Nab-Paclitaxel and Bevacizumab in Treating Patients With Unresectable Stage IV Melanoma or Gynecological Cancers

Official Title

Targeted Complex Therapy for Advanced Melanoma, Gynecologic Cancers, and Other Malignancies: Nab-Paclitaxel (Abraxane)/Bevacizumab Complex (AB-Complex)

Brief Summary

      This phase I trial studies the side effects and best dose of nab-paclitaxel and bevacizumab
      in treating patients with stage IV melanoma that cannot be removed by surgery (unresectable),
      cancer of the cervix, endometrium, ovary, fallopian tube or peritoneal cavity. Drugs used in
      chemotherapy, such as nab-paclitaxel, 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. Bevacizumab may stop or slow tumor growth by blocking the growth of new blood
      vessels necessary for tumor growth. Giving nab paclitaxel and bevacizumab may kill more tumor
      cells than nab-paclitaxel alone.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the maximally tolerated dose (MTD-malignant melanoma [MM]) of Abraxane
      (nab-paclitaxel)/bevacizumab-complex (AB-complex) among patients with metastatic malignant
      melanoma.

      II. To determine the maximally tolerated dose (MTD-gynecologic [GYN]) of AB-complex among
      patients with gynecologic cancers.

      III. To further assess the safety profile and anti-tumor activity of the recommended phase II
      dose of AB-complex for patients with previously-treated endometrial cancer IV. To further
      assess the safety profile and anti-tumor activity of the recommended phase II dose of
      AB-complex for patients with previously treated ovarian cancer

      SECONDARY OBJECTIVES:

      I. To gather preliminary data on tumor response rate and progression free survival time of
      AB-complex among patients with metastatic malignant melanoma.

      II. To gather preliminary data on tumor response rate and progression free survival time of
      AB-complex among patients with gynecologic cancers.

      CORRELATIVE OBJECTIVES (DOSE-ESCALATION COHORTS ONLY):

      I. Pharmacokinetics of paclitaxel administered in the context of AB-complex. II. Tumor
      concentrations of paclitaxel 24 hour (h) following AB-complex infusion and correlation with
      plasma levels.

      OUTLINE: This is a dose-escalation study.

      Patients receive nab-paclitaxel/bevacizumab-complex intravenously (IV) over 30-60 minutes on
      days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up every 6 months for 12 months.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum tolerated dose

Secondary Outcome

 Tumor response

Condition

Cervical Adenocarcinoma

Intervention

Bevacizumab

Study Arms / Comparison Groups

 Treatment (AB-complex)
Description:  Patients receive nab-paclitaxel/bevacizumab-complex IV over 30-60 minutes on days 1, 8, and 15. Cycles repeat every 28 days 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

Biological

Estimated Enrollment

73

Start Date

March 26, 2014

Completion Date

June 1, 2025

Primary Completion Date

February 3, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Melanoma cohort only: histologic proof of surgically unresectable stage IV malignant
             melanoma

          -  Melanoma cohort only: measurable disease defined as at least one lesion whose longest
             diameter can be accurately measured as >= 2.0 cm with chest x-ray, or as >= 1.0 cm
             with computed tomography (CT) scan or magnetic resonance imaging (MRI) scan; or CT
             component of a positron emission tomography (PET)/CT; NOTE: disease that is measurable
             by physical examination only is not eligible

          -  Gynecologic cancer cohorts only (dose escalation and dose expansion cohorts)

               -  Dose escalation cohort only: Histologic proof of epithelial cervical,
                  endometrial, ovarian, fallopian, or primary peritoneal cancers; allowable
                  histologies for cervical cancer include squamous cell carcinoma, adenocarcinoma,
                  and mixed/adenosquamous carcinoma; allowable histologies for endometrial cancer
                  include endometrioid, serous, clear cell, mucinous, squamous, transitional cell,
                  undifferentiated, mixed, and carcinosarcoma (this is considered a poorly
                  differentiated epithelial tumor); allowable histologies for ovarian, fallopian,
                  and peritoneal cancer include serous, clear cell, endometrioid, mucinous,
                  transitional cell, undifferentiated, mixed, and carcinosarcoma

          -  Endometrial cancer expansion cohort only:

               -  Histologic proof of endometrial cancer including endometrioid, serous, clear
                  cell, mucinous, undifferentiated, mixed, and carcinosarcoma histologies

               -  1-3 lines of cytotoxic or immune checkpoint inhibitor therapy (not including
                  hormonal therapy or other regimens not containing cytotoxic agents or immune
                  checkpoint inhibitors)

                    -  If one (1) prior line of therapy, must have contained a taxane, a platinum
                       drug, and and immune checkpoint inhibitor

                    -  If 2-3 prior lines of therapy, at least one must have contained a taxane and
                       a platinum drug, and at least one must have contained an immune checkpoint
                       inhibitor

          -  Ovarian cancer expansion cohort only:

               -  Histologic proof of ovarian cancer including high grade serous, endometrioid,
                  clear cell, mucinous, transitional cell, undifferentiated, mixed, and
                  carcinosarcoma histologies

               -  1-4 lines of cytotoxic chemotherapy (not including hormonal therapy or other
                  non-cytotoxic regimens)

                    -  At least one prior line of chemotherapy must have contained a taxane and a
                       platinum agent

                    -  If 1 or 2 prior lines of chemotherapy, patient's disease must be
                       platinum-resistant

                         -  NOTE: Platinum-resistance is defined as any of the following occurring
                            < 183 days after the last dose of platinum-based chemotherapy:

                              -  Development of measurable disease (per Response Evaluation
                                 Criteria in Solid Tumors [RECIST] 1.1)

                              -  Progression of radiographic disease (per RECIST 1.1)

                              -  Increase in CA-125 level to >= 2 x upper limit of normal (ULN) (if
                                 within normal limits [WNL] at the completion of platinum-based
                                 chemotherapy)

                                   -  If CA-125 is used to determine the date of progression then
                                      it must be confirmed by a second CA-125 value >= 7 days after
                                      the first level; the date of the first qualifying CA-125 is
                                      used to compute the platinum-free interval

                              -  Increase in CA-125 level to >= 2 x nadir (if nadir > ULN)

                                   -  If CA-125 is used to determine the date of progression then
                                      it must be confirmed by a second CA-125 value >= 7 days after
                                      the first level; the date of the first qualifying CA-125 is
                                      used to compute the platinum-free interval

                    -  If 3-4 prior lines of chemotherapy, may be platinum-resistant or
                       platinum-sensitive

               -  At least one prior line of cytotoxic chemotherapy must also have contained
                  bevacizumab

          -  Dose escalation cohort: For ovarian, fallopian tube, and peritoneal cancers only: Must
             meet criteria for one option below:

               -  Platinum-resistant, defined as =< 183 days from the date of the most recent dose
                  of chemotherapy containing either carboplatin or cisplatin until the first
                  evidence of cancer recurrence or progression (either symptoms directly
                  attributable to cancer, radiographic recurrence of cancer, or cancer antigen 125
                  [CA-125] > 70), confirmed >= 7 days later (confirmation of elevated CA-125 may be
                  beyond 183 days and still count as platinum-resistant)

               -  Prior allergic reaction to carboplatin or cisplatin

          -  Measurable disease, defined as at least one lesion whose longest diameter can be
             accurately measured as >= 2.0 cm with chest x-ray, or as >= 1.0 cm with CT scan or MRI
             scan; or CT component of a PET/CT; NOTE: Disease that is measurable by physical
             examination only is not eligible; EXCEPTION: Patients with ovarian, fallopian, or
             peritoneal cancer without measurable disease are eligible if two pretreatment CA125
             values (documented on two occasions taken at least one week apart) are at least twice
             the upper limit of normal or twice the nadir value if pretreatment CA125 values never
             normalized.

          -  At least one prior systematic therapy in the metastatic setting

               -  NOTE: exception for patients with metastatic uveal or mucosal melanoma for which
                  there are no effective/approved front line systemic treatments

          -  Hemoglobin >= 9.0 g/dL (patients may be transfused to meet hemoglobin [Hgb]
             requirement) (obtained =< 14 days prior to registration)

          -  Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 14 days prior to
             registration)

          -  Platelet count (PLT) >= 100,000/mm^3 (obtained =< 14 days prior to registration)

          -  Total bilirubin =< 1.5 mg/dL or direct bilirubin =< 0.4 mg/dL (obtained =< 14 days
             prior to registration)

          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =<
             2.5 x ULN (obtained =< 14 days prior to registration)

          -  Creatinine =< 1.5 x ULN (obtained =< 14 days prior to registration)

          -  Alkaline phosphatase =< 2.5 x ULN (obtained =< 14 days prior to registration)

          -  Absence of proteinuria at screening as demonstrated by one of the following (obtained
             =< 14 days prior to registration):

               -  Urine protein/creatinine (UPC) ratio < 1.0 at screening OR

               -  Urine dipstick for proteinuria < 2+ (patients discovered to have >= 2+
                  proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine
                  collection and must demonstrate =< 1 g of protein in 24 hours to be eligible)

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

          -  Sensory peripheral neuropathy =< grade 1 (per Common Terminology Criteria for Adverse
             Events [CTCAE] version [v.] 4.0)

          -  Motor peripheral neuropathy = grade 0 (per CTCAE v. 4.0)

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Willing to return to enrolling institution for follow-up 2-4 weeks after treatment
             discontinuation

          -  Life expectancy >= 90 days (3 months)

          -  Willing to provide blood samples for correlative research purposes

          -  Negative pregnancy test done =< 7 days prior to registration, for persons of
             childbearing potential only

        Exclusion Criteria:

          -  Known standard therapy for the patient's disease that is potentially curative or
             definitely capable of extending life expectancy; EXCEPTION: For platinum-resistant
             ovarian cancer, because nab-paclitaxel has known benefit, patients who may benefit
             from standard single agent chemotherapy are also eligible to participate

          -  Prior therapy with an angiogenesis inhibitor =< 28 days prior to registration

          -  No more than 3 systemic therapies (cytotoxic or immunologic) =< 2 years prior to
             registration

          -  Melanoma cohort only: Treatment with ipilimumab =< 6 months prior to registration.

          -  Any anti-cancer therapy or investigational agents =< 4 weeks prior to registration

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

          -  Failure to fully recover from acute, reversible effects of prior chemotherapy
             regardless of interval since last treatment

          -  Brain metastases per MRI or CT at any time prior to registration; NOTE: patients who
             have had primary therapy for brain metastasis (i.e. surgical resection, whole brain
             radiation, or stereotactic radiotherapy [SRT] even if stable) are not eligible

          -  Any of the following because this study involves an investigational agent whose
             genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
             unknown:

               -  Pregnant persons

               -  Nursing persons

               -  Persons of childbearing potential who are unwilling to employ adequate
                  contraception

          -  Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
             of the investigator, would make the patient inappropriate for entry into this study or
             interfere significantly with the proper assessment of safety and toxicity of the
             prescribed regimens

          -  Other active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic
             skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history of prior
             malignancy, they must not be receiving other specific treatment for their cancer

          -  Other medical conditions including but not limited to:

               -  History of liver disease such as cirrhosis, chronic active hepatitis, chronic
                  persistent hepatitis or hepatitis B or C

               -  Active infection requiring parenteral antibiotics

               -  Immuno-compromised patients and patients known to be human immunodeficiency virus
                  (HIV) positive and currently receiving antiretroviral therapy; NOTE: patients
                  known to be HIV positive, but without clinical evidence of an immunocompromised
                  state, are eligible for this trial

               -  New York Heart Association class II-IV congestive heart failure (serious cardiac
                  arrhythmia requiring medication)

               -  Myocardial infarction or unstable angina =< 6 months prior to registration

               -  Congestive heart failure requiring use of ongoing maintenance therapy for
                  life-threatening ventricular arrhythmias

               -  Clinically significant peripheral vascular disease

               -  History of central nervous system (CNS) disease (e.g., primary brain tumor,
                  vascular abnormalities, etc.), clinically significant stroke or transient
                  ischemic attack (TIA) =< 6 months prior to registration, seizures not controlled
                  with standard medical therapy

               -  History of hypertensive crisis or hypertensive encephalopathy

               -  Therapeutic anticoagulation requiring international normalized ratio (INR) > 2.0

               -  Conditions that increase the risk of venous thrombosis and/or pulmonary emboli
                  including, but not limited to: prior history of deep venous thrombosis or
                  pulmonary emboli, atrial fibrillation, paroxysmal atrial fibrillation, known and
                  documented thrombophilia requiring long term anticoagulation therapy, permanent
                  intravenous indwelling catheters, severe obesity (body mass index [BMI] > 40)

          -  For gynecologic cancer cohort only (dose escalation and dose expansion cohorts):
             Recurrent or progressive disease within 30 days of the last dose of weekly paclitaxel
             or nab-paclitaxel

          -  History of inflammatory bowel disease requiring ongoing therapy

          -  History of diverticulitis or pancreatitis =< 6 months prior to registration

          -  History of grade 3 or 4 bowel toxicity from immune checkpoint inhibitor =< 12 weeks
             prior to registration

          -  Invasive surgery =< 6 weeks prior to registration, or planned elective invasive
             surgery during study treatment.

        NOTE: Patients with recent minor surgical procedures with minimal risk for wound healing
        complications may register =< 6 weeks after the procedure with documented approval by the
        surgical team
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Matthew S Block, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02020707

Organization ID

MC1371

Secondary IDs

NCI-2013-01782

Responsible Party

Sponsor

Study Sponsor

Mayo Clinic

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Matthew S Block, Principal Investigator, Mayo Clinic in Rochester


Verification Date

May 2021