Dasatinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer

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Brief Title

Dasatinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer

Official Title

Pilot and Translational Study of Dasatinib (NSC#732517) Paclitaxel and Carboplatin in Women With Advanced Stage and Recurrent Endometrial Cancer

Brief Summary

      This pilot phase I trial studies how well dasatinib works together with paclitaxel and
      carboplatin in treating patients with stage III, stage IV, or endometrial cancer that has
      come back after a period of improvement. Dasatinib may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as
      paclitaxel and 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.
      Giving dasatinib together with paclitaxel and carboplatin may kill more tumor cells.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To evaluate pMEK and EphA2 signaling effectors in pre- and post- treatment biopsy tissues
      from patients with advanced staged measurable primary or recurrent endometrial cancer.

      SECONDARY OBJECTIVES:

      I. To determine the frequency and severity of adverse events as assessed by Common
      Terminology Criteria for Adverse Events version 4 (CTCAE v. 4) of dasatinib administered in
      combination with paclitaxel and carboplatin in patients with advanced staged measurable
      primary or recurrent endometrial cancer.

      II. To record the objective response rate by Response Evaluation Criteria in Solid Tumors
      (RECIST) v.1.1.

      III. To describe the progression-free survival and overall survival.

      TERTIARY OBJECTIVES:

      I. To explore the relationship of micro ribonucleic acid (RNA) 520d-3p (miR520d-3p) and EphA2
      in pretreatment biopsies.

      II. To evaluate downstream EphA2 signaling effectors, such as CAV-1, pAKT, FAK, paxillin, and
      p130cas in pre- and post-tissue treatment biopsies.

      III. To explore the effect of dasatinib on the expression of other Eph family members such as
      EphB2 and EphB4.

      IV. To quantify circulating tumor cells (CTCs) before and during the individual treatment
      phases.

      OUTLINE:

      Patients receive induction therapy comprising dasatinib orally (PO) once daily (QD) for 14
      days. *Beginning 7 days later, patients receive paclitaxel intravenously (IV) over 3 hours
      and carboplatin IV on day 1, and dasatinib PO QD on days 1-21. Treatment repeats every 21
      days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

      NOTE: * Patients who have had prior external-beam pelvic or extended-field pelvic/para-aortic
      radiation therapy must receive treatment at a reduced dose.

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

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Change in pMEK expression

Secondary Outcome

 Response rate (complete [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors version 1.1

Condition

Endometrial Adenocarcinoma

Intervention

Carboplatin

Study Arms / Comparison Groups

 Treatment (dasatinib, paclitaxel, carboplatin)
Description:  Patients receive induction therapy comprising dasatinib PO QD for 14 days. *Beginning 7 days later, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1, and dasatinib PO QD on days 1-21. Treatment repeats every 21 days for up to 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

18

Start Date

September 20, 2011

Completion Date

December 31, 2015

Primary Completion Date

December 31, 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have measurable stage III, stage IV, or recurrent endometrial carcinoma
             whose potential for cure by surgery or radiation therapy alone is poor

          -  Patients with the following histologic epithelial cell types are eligible:
             endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear
             cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise
             specified (N.O.S.), mucinous adenocarcinoma, squamous cell, transitional cell
             carcinoma, and mesonephric carcinoma; uterine carcinosarcoma are not eligible for
             either COHORT

          -  All patients must have measurable disease; measurable 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 >= 20 mm when measured by conventional
             techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic
             resonance imaging (MRI), or >= 10 mm when measured by spiral CT; measurable disease
             lesions must be amenable to pre- and post- treatment biopsy

          -  Patients must have at least one "target lesion" to be used to assess response on this
             protocol as defined by RECIST; tumors within a previously irradiated field will be
             designated as "non-target" lesions unless progression is documented or a biopsy is
             obtained to confirm persistence at least 90 days following completion of radiation
             therapy

          -  Patients must have a Gynecologic Oncology Group (GOG) performance status of 0 to 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

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

          -  Patients should have had NO prior chemotherapy agents for advanced or recurrent
             endometrial cancer; prior chemotherapy administration in conjunction with primary
             radiation therapy as a radiosensitizer would not exclude a patient from participation
             in this trial

          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL, equivalent to
             Common Terminology Criteria (CTCAE version [v]4) grade 1

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

          -  Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE
             v4 grade 1

          -  Bilirubin less than or equal to 1.5 x ULN (CTCAE v4 grade 1)

          -  Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 2.5 x ULN (CTCAE
             v4 grade 1)

          -  Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4 grade 1)

          -  Neuropathy (sensory and motor) less than or equal to CTCAE v4 grade 1

          -  Therapeutic anticoagulation is not contraindicated, but for those patients on
             therapeutic anticoagulation, alteration in coagulation parameters is expected
             following initiation of dasatinib; for patients on therapeutic anticoagulation,
             coagulation parameters should be assessed weekly for the first cycle following
             initiation of dasatinib, weekly for the first cycle following a dose reduction, and
             weekly for a minimum of two weeks after stopping dasatinib

          -  Warfarin is permitted for prophylaxis or treatment of thrombosis; Note: low-molecular
             weight heparin is permitted provided the patient's prothrombin time (PT)/international
             normalized ratio (INR) is =< 1.5; for patients on anticoagulation, coagulation
             parameters should be assessed weekly for the first cycle following initiation of
             dasatinib, weekly for the first cycle following a dose reduction, and weekly for a
             minimum of two weeks after stopping dasatinib

          -  PT such that INR is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient
             is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT)
             =< 1.5 times the institutional upper limit of normal; patients receiving low-molecular
             weight heparin for the prevention or treatment of venous thromboembolic disease are
             eligible if considered clinically stable on their regimen

          -  Oxygen saturation greater than or equal to 88% on room air (CTCAE 4 < grade 2)

          -  Patients must have a baseline electrocardiogram (EKG) performed prior to enrolling on
             study; the EKG must have corrected QT interval (QTc) < 450 msec and must not show
             evidence of serious ventricular arrhythmia (ventricular tachycardia or ventricular
             fibrillation must be less than 3 beats in a row)

          -  Cardiac ejection fraction must be within the institutional range of normal as measured
             by left ventricular ejection fraction (LVEF) testing; note that baseline and on
             treatment scans should be performed using the same modality and preferably at the same
             institution

          -  Patients must have signed an approved informed consent

          -  Patients of childbearing potential must have a negative serum pregnancy test prior to
             study entry and be practicing an effective form of contraception during the study and
             for at least 6 months after receiving the final treatment of dasatinib

          -  Patients must be able to swallow whole tablets

          -  Patients may not have any clinically significant cardiovascular disease including the
             following:

               -  Myocardial infarction or ventricular tachyarrhythmia within 6 months

               -  Prolonged QTc >= 480 msec (Fridericia correction)

               -  Ejection fraction less than institutional normal

               -  Major conduction abnormality (unless a cardiac pacemaker is present)

               -  Patients with any cardiopulmonary symptoms of unknown cause (e.g. shortness of
                  breath, chest pain, etc.) should be evaluated by a baseline echocardiogram with
                  or without stress test as needed in addition to electrocardiogram (EKG) to rule
                  out QTc prolongation; the patient may be referred to a cardiologist at the
                  discretion of the principal investigator; patients with underlying
                  cardiopulmonary dysfunction should be excluded from the study

        Exclusion Criteria:

          -  Patients who have isolated recurrences (vaginal, pelvic, or para-aortic) that are
             amenable to potentially curative treatment with radiation therapy or surgery

          -  Patients who have had a prior chemotherapy regimen for advanced or metastatic disease
             are excluded; patients who received adjuvant chemotherapy must be disease-free for at
             least 6 months

          -  Patients may have received prior radiation therapy for treatment of endometrial
             carcinoma; prior radiation therapy may have included pelvic radiation therapy,
             extended field pelvic/para-aortic radiation therapy, and/or intravaginal
             brachytherapy, alone or with chemotherapy as a radiation sensitizer; all radiation
             therapy must be completed at least 4 weeks prior to the first date of study therapy;
             the prior radiation field, radiation dose, number of fractions and prior radiation
             start and stop dates must be provided at registration

          -  Patients who have previously received dasatinib; additionally, patients may not be
             receiving any other investigational agents; patients may have received prior hormonal
             therapy for treatment of endometrial carcinoma; all hormonal therapy must be
             discontinued at least one week prior to the first date of study therapy; patients with
             known brain metastases should be excluded from this clinical trial

          -  Patients with serious, non-healing wound, ulcer, or bone fracture; this includes
             history of abdominal fistula or gastrointestinal perforation; patients with an
             intra-abdominal abscess within 28 days prior to the first date of dasatinib therapy
             are ineligible

          -  Patients with active bleeding or pathologic conditions that carry high risk of
             bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major
             vessels; patients who have a history of significant bleeding disorder unrelated to
             cancer including:

               -  Bleeding diathesis, congenital or acquired within one year prior to initiating
                  protocol therapy (e.g. von Willebrand's disease, acquired anti-factor VIII
                  antibodies); significant gastrointestinal (GI) bleeding within three months prior
                  to initiating protocol therapy

          -  Patients with history or evidence upon physical examination of central nervous system
             (CNS) disease (treated or untreated), including primary brain tumor, seizures not
             controlled with standard medical therapy, or any brain metastases

          -  Patients who have had radiotherapy within 4 weeks prior to entering the study or those
             who have not recovered from adverse events (CTCAE v4 grade 2 or greater, excluding
             alopecia) due to agents administered more than 4 weeks earlier

          -  Patients cannot take St. John's wort or drink grapefruit juice while on study
             treatment (discontinue St. John wort at least five days before starting dasatinib)

          -  Patients who have an active pleural or pericardial effusion of any grade

          -  Patients receiving IV bisphosphonates agree that IV bisphosphonates will be withheld
             for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia, and may be
             restarted only if any hypocalcemia has been corrected

          -  Patients with clinically significant cardiovascular disease; this includes:

               -  Uncontrolled hypertension, defined as systolic > 140 mmHg or diastolic > 90 mm Hg

               -  Myocardial infarction or unstable angina within 6 months of the first date of
                  dasatinib therapy

               -  New York Heart Association (NYHA) class II or greater congestive heart failure or
                  serious cardiac arrhythmia requiring medication; this would include women with
                  atrial fibrillation, who require rate-controlling medication

               -  CTCAE v4 grade 2 or greater peripheral vascular disease

               -  History of cerebrovascular accident (CVA, stroke), transient ischemic attack
                  (TIA), or subarachnoid hemorrhage within six months of the first date of
                  dasatinib therapy

               -  Patients with hypokalemia or hypomagnesemia if it cannot be corrected to within
                  normal limits prior to dasatinib treatment

               -  Required use of a concomitant medication that can prolong the QT interval

          -  Patients may not be receiving any prohibited potent cytochrome P450, family 3,
             subfamily A, polypeptide 4 (CYP3A4) inhibitors; for these drugs, a washout period of
             greater than or equal to 7 days is required prior to starting dasatinib treatment

          -  The concomitant use of histamine (H2) blockers and proton pump inhibitors (PPI's) with
             dasatinib is not recommended (e.g., famotidine, omeprazole); the use of antacids
             should be considered in place of H2 blockers or PPIs in patients receiving dasatinib
             therapy; if antacid therapy is needed, the antacid dose should be administered two
             hours before or after the dose of dasatinib

          -  Patients may not be receiving any other investigational agents

          -  Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
             therapy are ineligible

          -  Patients who are pregnant or nursing; women of child-bearing potential and men must
             agree to use adequate contraception (hormonal or barrier method of birth control;
             abstinence) prior to study entry and for the duration of study participation; should a
             woman become pregnant or suspect she is pregnant while participating in this study,
             she should inform her treating physician immediately

          -  Uterine carcinosarcoma and other sarcomas of the uterus will be excluded
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Robert Coleman, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01440998

Organization ID

NCI-2011-03275

Secondary IDs

NCI-2011-03275

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Robert Coleman, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

April 2018