Bevacizumab, Capecitabine, and Oxaliplatin in Treating Advanced Small Intestinal or Ampulla of Vater Adenocarcinoma

NCT01208103 | Completed Phase 2 Results FDA Drug

• 4 other identifiers: 2009-0626NCI-2018-01828NCI-2011-00470P30CA016672
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well bevacizumab given with capecitabine and oxaliplatin work in treating participants with small bowel or ampulla of Vater adenocarcinoma that has spread to other places in the body. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs using in chemotherapy, such as capecitabine and oxaliplatin, 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 bevacizumab, capecitabine, and oxaliplatin may work better in treating participants with small intestinal or ampulla of Vater adenocarcinoma.

Conditions

Ampulla of Vater Adenocarcinoma; Small Intestinal Adenocarcinoma; Stage III Ampulla of Vater Cancer AJCC v8; Stage III Small Intestinal Adenocarcinoma AJCC v8; Stage IIIA Ampulla of Vater Cancer AJCC v8; Stage IIIA Small Intestinal Adenocarcinoma AJCC v8; Stage IIIB Ampulla of Vater Cancer AJCC v8; Stage IIIB Small Intestinal Adenocarcinoma AJCC v8; Stage IV Ampulla of Vater Cancer AJCC v8; Stage IV Small Intestinal Adenocarcinoma AJCC v8

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Progression-free Survival (PFS) at Six Months

  A Bayesian sequential monitoring design will be used. PFS will be estimated using the Kaplan-Meier method.The length of time interval in months from date of first treatment, during and after the treatment a participant lives without progression.

  6 months

Secondary Outcomes (4)

• To Determine the Response Rate (RR) for CAPOX and Bevacizumab

  39 months

• To Determine the Overall PFS for CAPOX and Bevacizumab

  39 months

• To Determine the Overall Survival (OS) for CAPOX and Bevacizumab

  39 months

• Number of Participants With Adverse Events

  39 months

Study Arms (1)

Treatment (oxaliplatin, bevacizumab, capecitabine)

EXPERIMENTAL

Participants receive oxaliplatin via CVC over 2 hours and bevacizumab IV over 30-90 minutes on day 1. Participants also receive capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Biological: Bevacizumab; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Bevacizumab BIOLOGICAL

Given IV

Also known as: Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar QL 1101, BEVACIZUMAB, LICENSE HOLDER UNSPECIFIED, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF

Treatment (oxaliplatin, bevacizumab, capecitabine)

Capecitabine DRUG

Given PO

Also known as: Ro 09-1978/000, Xeloda

Treatment (oxaliplatin, bevacizumab, capecitabine)

Oxaliplatin DRUG

Given CVC

Also known as: 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669

Treatment (oxaliplatin, bevacizumab, capecitabine)

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
• Prior adjuvant chemotherapy (including fluorouracil \[5-FU\], capecitabine, and oxaliplatin) for the treatment of adenocarcinoma of the small bowel or ampulla of Vater is allowed if completed \>= 52 weeks prior to first dose of study treatment
• Prior capecitabine or 5-FU administered as a radio-sensitizing agent concurrently with external beam radiotherapy is allowed
• Patients must have metastatic disease
• A minimum of 4 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 to 2
• Absolute neutrophil count (ANC) \>= 1,500/ul
• Platelets \>= 100,000/ul
• Total bilirubin =\< 1.5 x upper limit of normal (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
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \< 3 x ULN
• Calculated creatinine clearance (CrCl) \> 50 cc/min (calculated using the Cockcroft and Gault formula)
• Negative serum or urine 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
• 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
• The effects of the combination of CAPOX and bevacizumab 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

You may not qualify if:

• Patients who have received prior chemotherapy for their metastatic disease are excluded. Chemotherapy if given as a radiation-sensitizer is allowed
• Patients may not be receiving any other investigational agents nor have received any investigational drug 28 days prior to enrollment
• Known history of dihydropyrimidine (DPD) deficiency
• Peripheral neuropathy of grade 3 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0
• Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
• Because of the interaction between coumadin and capecitabine, patients taking therapeutic doses of coumadin-derivative anticoagulants are not eligible. Low-dose coumadin (e.g. 1 mg PO per day) in patients with in-dwelling venous access devices is allowed but increased frequency of international normalized ratio (INR) monitoring is recommended
• Prior treatment with bevacizumab or known hypersensitivity to any component of bevacizumab
• Inadequately controlled hypertension (defined as systolic blood pressure \>140 mmHg and/or diastolic blood pressure \> 90 mmHg)
• Prior history of hypertensive crisis or hypertensive encephalopathy
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• New York Heart Association (NYHA) grade II or greater congestive heart failure
• History of myocardial infarction or unstable angina within 6 months prior to day 1
• History of stroke or transient ischemic attack within 6 months prior to day 1.
• Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to day 1
• History of hemoptysis (\>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to day 1

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

Bevacizumab; Immunoglobulin G; Disulfides; Capecitabine; Oxaliplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Isotypes; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes

Results Point of Contact

• Title: Dr. Michael Overman/Gastrointestinal Medical Oncology
• Organization: UT MD Anderson Cancer Center

MOverman@mdanderson.org

713-745-4317

Study Officials

• Michael Overman

  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: August 31, 2010
• First Posted: September 23, 2010
• Study Start: May 6, 2011
• Primary Completion: March 7, 2018
• Study Completion: March 7, 2018
• Last Updated: September 3, 2020
• Results First Posted: January 18, 2020

Record last verified: 2020-09

Locations

US (1)