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

CAPOX in <span class="go-doc-concept go-doc-biomarker">KRAS</span> Wild-Type Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater

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

    NCT ID: NCT01202409

    ORG ID: 2009-0458

    NCI ID: NCI-2012-01894

    Trial Conditions

    Gastrointestinal Cancer

    Trial Interventions

    Drug Synonyms Arms
    Panitumumab Vectibix Panitumumab

    Trial 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

    Name Type Description Interventions
    Panitumumab Experimental Starting 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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Response Rate (RR) of Patients

    Secondary Outcome Measures

    Trial Keywords

    Ampulla of Vater

    Adenocarcinoma of the small bowel

    Metastatic

    Kirsten rat sarcoma

    KRAS

    Capecitabine

    Xeloda

    Oxaliplatin

    Eloxatin

    CAPOX

    Panitumumab

    Vectibix