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

NCT01202409 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2009-0458NCI-2012-01894
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response Rate (RR)

  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.

  up to 100 weeks

Secondary Outcomes (1)

• Overall Progression-free Survival (PFS) for CAPOX and Panitumumab

  7.6 months

Study Arms (1)

Panitumumab

EXPERIMENTAL

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

Drug: Panitumumab

Interventions

Panitumumab DRUG

Starting Dose Level: 9 mg/kg by vein over 60 minutes on day 1 of a 14 day cycle.

Also known as: Vectibix

Panitumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed adenocarcinoma of the small bowel or ampulla of Vater that is either unresectable or metastatic.
• Adequate tumor tissue available for KRAS mutational analysis or known KRAS wild-type status.
• 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.
• Patients must have measurable disease as per the revised Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).
• If radiation was previously received, the measurable disease must be outside the previous radiation field, unless this area has demonstrated evidence of radiographic growth.
• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2.
• 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.
• 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.
• 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.
• 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.
• Magnesium level =/\> lower limit of normal.

You may not qualify if:

• 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.
• Patients may not be receiving any other investigational agents nor have received any investigational drug 30 days prior to enrollment.
• 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.
• Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.
• 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.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Amgen: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Gulhati P, Raghav K, Shroff R, Varadhachary G, Javle M, Qiao W, Wang H, Morris J, Wolff R, Overman MJ. Phase II Study of Panitumumab in RAS Wild-Type Metastatic Adenocarcinoma of Small Bowel or Ampulla of Vater. Oncologist. 2018 Mar;23(3):277-e26. doi: 10.1634/theoncologist.2017-0568. Epub 2017 Dec 19.

  PMID: 29259073 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Neoplasm Metastasis

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Michael J Overman/ Professor, GI Medical Oncology
• Organization: UT MD Anderson Cancer Center

moverman@mdanderson.org

713-745-4317

Study Officials

• Michael Overman, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 15, 2010
• Study Start: November 2, 2010
• Primary Completion: July 3, 2018
• Study Completion: July 3, 2018
• Last Updated: February 21, 2020
• Results First Posted: February 21, 2020

Record last verified: 2020-02

Locations

US (1)