Clinical Trials /

(IMPACT II) Molecular Profiling and Targeted Therapy in Treating Patients With Metastatic Cancer

NCT02152254

Description:

This randomized clinical trial studies how molecular profiling and targeted therapy work in treating patients with cancer that has spread to other places in the body compared to standard treatment. Information about genetic differences in a patient's tumor can be used to choose treatment that may target the tumor. It is not yet validated whether selecting treatment after studying the genetic changes that are associated with cancer in a patient's tumor is a better way to treat patients with metastatic cancer compared to therapy not based on studying the genetic changes that are associated with cancer.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: (IMPACT II) Molecular Profiling and Targeted Therapy in Treating Patients With Metastatic Cancer
  • Official Title: Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer: Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT II)

Clinical Trial IDs

  • ORG STUDY ID: PA12-1161
  • SECONDARY ID: NCI-2016-00830
  • SECONDARY ID: PA12-1161
  • SECONDARY ID: P30CA016672
  • NCT ID: NCT02152254

Conditions

  • Metastatic Malignant Neoplasm
  • Recurrent Malignant Neoplasm

Interventions

DrugSynonymsArms
Targeted Therapy Based on Molecular ProfilingArm A: Targeted Therapy
Standard-of-Care TherapyArm B: Standard-of-Care Therapy

Purpose

This randomized clinical trial studies how molecular profiling and targeted therapy work in treating patients with cancer that has spread to other places in the body compared to standard treatment. Information about genetic differences in a patient's tumor can be used to choose treatment that may target the tumor. It is not yet validated whether selecting treatment after studying the genetic changes that are associated with cancer in a patient's tumor is a better way to treat patients with metastatic cancer compared to therapy not based on studying the genetic changes that are associated with cancer.

Detailed Description

      I. To determine whether patients treated with a matched targeted therapy selected on the
      basis of genomic alteration analysis of the tumor have longer progression-free survival from
      the time of randomization than those whose treatment is not selected on the basis of
      alteration analysis.

      OUTLINE: After completion of molecular profiling, patients who qualify for the trial will be
      offered randomization as previously. If they wish to be randomized, patients will be
      randomized to one of the two arms: matched targeted therapy (ARM I) or other therapy (ARM
      II). Patients who decline to be randomized will then be offered their choice of the two trial
      arms.

      ARM I: Matched targeted therapy: Molecular profiling results are used to assign targeted
      therapy. Patients receive targeted therapy by participating in a Phase I or a Phase II
      clinical trial. If a clinical trial is not available, and a commercially available targeted
      therapy exists (Food and Drug Administration [FDA]-approved for another indication), patients
      can receive the FDA-approved drug.

      ARM II: Other therapy: Patients receive standard of care therapy at the discretion of the
      treating physician.

      Patients with tumor progression who achieve the primary study endpoint can cross over to the
      other treatment arm.
    

Trial Arms

NameTypeDescriptionInterventions
Arm A: Targeted TherapyActive ComparatorPersonalized treatment, targeted therapy against the alteration based on molecular profiling.
  • Targeted Therapy Based on Molecular Profiling
Arm B: Standard-of-Care TherapyExperimentalStandard-of-Care treatment not selected on basis of alteration analysis.
  • Standard-of-Care Therapy

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with metastatic cancer

          -  Patients may have received unlimited lines of prior therapy

          -  Prior to randomization, patients with metastatic disease must have been treated with
             established standard-of-care therapy, or physicians have determined that such
             established therapy is not sufficiently efficacious, or patients have declined to
             receive standard-of-care therapy

          -  The patient has measurable disease

          -  The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  The patient has biopsy-accessible tumor; for patients who had no prior anticancer
             therapy and had surgical resection within a year and tumor tissue is immediately
             available, that tumor will be analyzed and no biopsy will be needed

          -  Absolute neutrophil count >= 1,000/ul

          -  Platelets >= 100,000/ul (unless these abnormalities are due to bone marrow
             involvement)

          -  Total bilirubin level <= 1.5 x the upper limit of normal (ULN), unless the patient has
             known Gilbert's disease

          -  Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase levels (SGPT) =<
             2.5 X ULN (unless the patient has liver metastases)

          -  Serum creatinine clearance >= 50 ml/min by the Cockcroft-Gault formula

          -  If the patient has brain metastasis, they must have been stable (treated and/or
             asymptomatic) and the patient must have been off steroids for at least 2 weeks

          -  The patient has provided signed informed consent

          -  Patients with a previous malignancy (other than the patients' known cancer) that were
             treated successfully and are disease-free for at least 3 years are allowed

          -  Patients with a history of basal cell carcinoma of the skin or pre-invasive carcinoma
             of the cervix are eligible

          -  Women of childbearing potential 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; childbearing potential will be defined as women who have had
             menses within the past 12 months and who have not had a tubal ligation, hysterectomy,
             or bilateral oophorectomy; should a woman become pregnant or suspect that she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

          -  Male subjects must agree to use effective contraception or abstinence while on study
             and for 90 days after last dose of study drug

        Exclusion Criteria:

          -  Patients who are randomized to the control arm must not receive therapy based on prior
             molecular profiling

          -  The patient has received chemotherapy, surgery, or radiotherapy (for therapeutic
             purposes) within 3 weeks of initiating study treatment (4 weeks for bevacizumab or
             investigational drugs) or the patient has not recovered (grade >= 2 from side effects
             of the previous therapy); patients who receive palliative radiation therapy can be
             treated immediately after completion of radiation therapy

          -  The patient has cardiac conditions as follows: uncontrolled hypertension (blood
             pressure [BP] > 160/100) despite optimal therapy, uncontrolled angina, ventricular
             arrhythmias, congestive heart failure (New York Heart Association class II or above),
             baseline left ventricular ejection fraction (LVEF) =< 50%, prior or current
             cardiomyopathy, atrial fibrillation with heart rate > 100 beats per minute (bpm),
             unstable ischemic heart disease (myocardial infarction [MI] within 6 months prior to
             starting treatment or angina requiring use of nitrates more than once weekly)

          -  The patient has peripheral neuropathy >= grade 2

          -  The patient is pregnant (confirmed by serum beta human chorionic gonadotropin [b-HCG],
             if applicable) or is breastfeeding

          -  The patient has concurrent severe and/or uncontrolled medical disease that could
             compromise participation in the study (i.e., uncontrolled diabetes, severe infection
             requiring active treatment, severe malnutrition, chronic severe liver or renal
             disease)

          -  The patient has refractory nausea and vomiting or chronic gastrointestinal diseases
             (e.g., inflammatory bowel disease) or has had significant bowel resection that would
             preclude adequate absorption (for oral therapy only)

          -  The patient is unable to swallow capsules and/or has a surgical or anatomical
             condition that precludes swallowing and absorbing oral medication on an ongoing basis
             (for oral therapy only)

          -  Any other condition that would, in the investigator's judgment, contraindicate the
             patient's participation in the clinical study due to safety concerns or compliance
             with clinical study procedures
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Comparison of Progression-Free Survival (PFS) Between the Two Randomized Arms
Time Frame:Continuous Monitoring, expected range from 2 months to 3 years
Safety Issue:
Description:Progression-free survival (PFS) of patients treated with a targeted therapy selected on the basis of mutational analysis of the tumor compared with PFS of those whose treatment is not selected based on alteration analysis.

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:M.D. Anderson Cancer Center

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