Clinical Trials /

CAPOX in KRAS Wild-Type Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater

NCT01202409

Description:

The goal of this clinical research study is to learn if panitumumab can help to control advanced cancer of the small bowel or ampulla of Vater. The safety of this drug will also be studied.

Related Conditions:
  • Ampulla of Vater Adenocarcinoma
  • Small Intestinal Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: CAPOX in KRAS Wild-Type Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater
  • Official Title: Phase II Study of Panitumumab in KRAS Wild-type Locally Advanced or Metastatic Adenocarcinoma of the Small Bowel or Ampulla of Vater

Clinical Trial IDs

  • ORG STUDY ID: 2009-0458
  • SECONDARY ID: NCI-2012-01894
  • NCT ID: NCT01202409

Conditions

  • Gastrointestinal Cancer

Interventions

DrugSynonymsArms
PanitumumabVectibixPanitumumab

Purpose

The goal of this clinical research study is to learn if panitumumab can help to control advanced cancer of the small bowel or ampulla of Vater. The safety of this drug will also be studied.

Detailed Description

      Panitumumab is designed to "turn off" a protein that is important in cell growth. This may
      stop the growth of cancer cells.

      Study Drug Administration:

      If you are found to be eligible to take part in this study, you will receive the study drug
      during 14 day study "cycles."

      On Day 1 of every cycle, you will receive panitumumab by vein over about 60-90 minutes.

      Study Visits:

      On or before Day 1 of each cycle:

        -  You will have a physical exam, including measurement of your weight.

        -  Your performance status will be recorded.

        -  You will be asked about any symptoms you may be experiencing and any drugs you may be
           taking.

        -  Blood (about 2 tablespoons) will be drawn for routine tests.

      Every 4 cycles:

        -  You will have a chest X-ray or a computed tomography (CT) scan of your chest to check
           the status of the disease.

        -  You will have a CT or MRI scan to check the status of the disease. If your scan shows
           that you are responding to the treatment, you will have another CT or MRI scan 6 weeks
           later.

      Length of Study:

      You may continue receiving the study drugs for as long as the doctor thinks it is in your
      best interest. You will no longer be able to take the study drugs if the disease gets worse
      or intolerable side effects occur.

      End-of-Treatment:

      After you stop taking the study drugs for any reason, you will have an end-of-treatment
      visit. The following tests and procedures will be performed:

        -  You will have a physical exam, including measurement of your weight.

        -  Your performance status will be recorded.

        -  You will be asked about any symptoms you may be experiencing and any drugs you may be
           taking.

        -  Blood (about 2 tablespoons) will be drawn for routine tests.

        -  If the doctor thinks it is needed, you will have a CT or MRI scan of the abdomen and
           pelvis to check the status of the disease.

      Follow-Up:

      Thirty (30) days after your last dose of study drug(s), you will be asked about any symptoms
      you may be experiencing and any drugs you may be taking. If you are unable to come to MD
      Anderson for this, the study staff will call you and ask you these questions. This call will
      last about 30 minutes.

      You will then be called every 3 months and asked the same questions. Each call will last
      about 15-30 minutes.

      If you are taken off study treatment for reasons other than the disease getting worse, you
      will have a CT or MRI scan of the abdomen and pelvis to check the status of the disease every
      12 weeks (+/- 2 weeks) after the End-of-Treatment visit. This will be done until the disease
      gets worse and if you do not start any other anti-cancer treatment.

      This is an investigational study. Panitumumab is commercially available and FDA approved to
      treat a certain type of colorectal cancer. Its use in this type of cancer is investigational.

      Up to 27 patients will take part in this study. All will be enrolled at MD Anderson.
    

Trial Arms

NameTypeDescriptionInterventions
PanitumumabExperimentalStarting Dose of Panitumumab: 9 mg/kg by vein over 60 minutes on day 1 of a 14 day cycle.
  • Panitumumab

Eligibility Criteria

        Inclusion Criteria:

          1. Patients must have histologically confirmed adenocarcinoma of the small bowel or
             ampulla of Vater that is either unresectable or metastatic.

          2. Adequate tumor tissue available for KRAS mutational analysis or known KRAS wild-type
             status.

          3. Prior progression on or intolerance to treatment with a fluoropyrimidine and
             oxaliplatin. Recurrence of disease within 6 months from the completion of adjuvant
             therapy with both a fluoropyrimidine and oxaliplatin is considered progression.

          4. Patients must have measurable disease as per the revised Response Evaluation Criteria
             In Solid Tumors (RECIST) criteria (Version 1.1).

          5. If radiation was previously received, the measurable disease must be outside the
             previous radiation field, unless this area has demonstrated evidence of radiographic
             growth.

          6. A minimum of 2 weeks must have elapsed from completion of any prior chemotherapy or
             radiotherapy or surgery and the start date of study therapy.

          7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2.

          8. Adequate organ function including: a) Absolute neutrophil count (ANC) =/>1,000/ul; b)
             Platelets =/>75,000/ul; c) Total bilirubin =/< 1.5 x ULN; in patients with known
             Gilbert's syndrome direct bilirubin =/<1.5 x ULN will be used as organ function
             criteria, instead of total bilirubin; d) AST (SGOT)/ALT (SGPT) < 3 x ULN; e)
             Creatinine <2 x ULN.

          9. Negative urine or serum pregnancy test in women with childbearing potential (defined
             as not post-menopausal for 12 months or no previous surgical sterilization), within
             one week prior to initiation of treatment.

         10. The effects of panitumumab on the developing fetus are unknown. For this reason, women
             of childbearing potential and men must agree to use adequate contraception (hormonal
             or barrier method of birth control) prior to study entry, for the duration of study
             participation, and for six months following the completion of therapy. Should a woman
             become pregnant while participating in this study, she should inform her treating
             physician immediately.

         11. Patients must sign an Informed Consent and Authorization indicating that they are
             aware of the investigational nature of this study and the known risks involved.

         12. Magnesium level =/> lower limit of normal.

        Exclusion Criteria:

          1. Prior anti-epidermal growth factor receptor antibody therapy (eg. panitumumab or
             cetuximab) or prior small molecule anti-epidermal growth factor receptor therapy (eg.
             erlotinib) for adenocarcinoma of the small bowel or ampulla of Vater.

          2. Patients may not be receiving any other investigational agents nor have received any
             investigational drug 30 days prior to enrollment.

          3. 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 adherence with
             study requirements.

          4. Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.

          5. Because there is an unknown but potential risk for adverse events in nursing infants
             secondary to treatment of the mother with panitumumab, breast feeding must be
             discontinued.

          6. Age <18 years. Because no dosing or adverse event data are currently available on the
             use of panitumumab in patients <18 years of age, children are excluded from this
             study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response Rate (RR)
Time Frame:up to 100 weeks
Safety Issue:
Description:Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary Outcome Measures

Measure:Overall Progression-free Survival (PFS) for CAPOX and Panitumumab
Time Frame:7.6 months
Safety Issue:
Description:Time interval in months from date of first treatment until the date of first documented progression of participants.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:M.D. Anderson Cancer Center

Trial Keywords

  • Ampulla of Vater
  • Adenocarcinoma of the small bowel
  • Metastatic
  • Kirsten rat sarcoma
  • KRAS
  • Capecitabine
  • Xeloda
  • Oxaliplatin
  • Eloxatin
  • CAPOX
  • Panitumumab
  • Vectibix

Last Updated

February 21, 2020