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Solid TumorPhase 1XADNCT00920868

XAD - Xelox (Capecitabine + Oxaliplatin) + Bevacizumab + Dasatinib

A Phase 1 study testing dasatinib, bevacizumab and Oxaliplatin in people with Solid Tumor and Metastatic Colorectal Cancer, run by Herbert Hurwitz, MD at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary purpose of this study is to find the highest tolerated dose of the study drugs: capecitabine, oxaliplatin, bevacizumab, and dasatinib given in combination to subjects with advanced solid tumors. This will occur in the first part of the study (Phase I). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Metastatic Colorectal Cancer
What is being tested?
dasatinib, bevacizumab and Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesUnited States
Study dates
May 2009to Aug 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Criteria Specific for Dose Escalation (Phase I)
  • Patients must have histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective, or for whom capecitabine, oxaliplatin, and/or bevacizumab would be considered a standard therapy or therapeutic option.
  • Patients must not have had radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within the 28 days prior to study day 1.
  • Criteria Specific for Expanded Cohort Portion of Trial Only
  • Histologically documented adenocarcinoma of the colon or rectum that is metastatic/recurrent disease
  • No prior chemotherapy for metastatic/recurrent colorectal cancer. Patients may have received a radiosensitizing dose of 5-fluorouracil or capecitabine for the treatment of local disease in the localized or metastatic setting.
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  • No history of other carcinomas within the last five years, except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer
  • Disease must be measurable by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
  • Age >18 years.
  • Karnofsky performance status > 70%.
  • Life expectancy of at least 3 months.
  • Patients must have adequate organ and marrow function as defined below:
  • Sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized.
  • All women of child bearing potential (WOCBP) MUST have a negative pregnancy test within 7 days prior to first receiving investigational product.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patients who have had radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for cancer within the 28 days prior to day 1 of the study (ie - first day of study drug treatment).
  • Patients who have received any other investigational agents within the 28 days prior to day 1 of study drug treatment.
  • Patients with known central nervous system (CNS) metastases.
  • Inadequately controlled hypertension
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  • Symptomatic peripheral vascular disease
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  • Evidence of bleeding diathesis or coagulopathy. Patients on full-dose anticoagulation are permitted to enroll provided that they have been clinically stable on anti- coagulation.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of study drug treatment
  • Core biopsy or other minor surgical procedure excluding placement of a vascular access device, within 7 days prior to expected start of treatment.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study day 1
  • Serious, non-healing wound, ulcer, or bone fracture
  • Proteinuria at screening
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 6 months prior to study treatment day 1
  • History of stroke or transient ischemic attack within 6 months prior to study treatment day 1
  • History of intolerance or hypersensitivity to prior treatment with capecitabine, oxaliplatin, bevacizumab and/or dasatinib.
  • No previous treatment with dasatinib.
  • Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Patient with grade 2 or greater peripheral neuropathy
  • Chronic treatment with systemic steroids or another immunosuppressive agent.
  • Other concurrent severe and/or poorly controlled medical condition that could compromise safety of treatment as so judged by treating physician.
  • A known history of HIV seropositivity,hepatitis C virus, acute or chronic active hepatitis B infection, or other serious chronic infection requiring ongoing treatment.
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or significant small bowel resection)
  • Patients unwilling to or unable to comply with the protocol
  • Diagnosed or congenital long QT syndrome
  • Any history of clinically significant ventricular arrhythmias
  • Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450 msec)
  • Pleural effusion grade > 2.
  • Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including:
  • History of significant bleeding disorder unrelated to cancer
  • Patients actively taking proton pump inhibitors or H2 antagonists will be excluded from this study.
  • Any psychiatric illness/social situations that would limit safety or compliance with study requirements
  • Medications that inhibit platelet function (except low dose aspirin as defined in study protocol)
  • Use of medications that are either Cytochrome P450 3A4 (CYP3A4) inhibitors or inducers

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Duke Univeristy Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and Dasatinib for Patients With Advanced Solid Tumors With Expanded Cohort of Patients With Previously Untreated Metastatic Colorectal Cancer.

The primary purpose of this study is to find the highest tolerated dose of the study drugs: capecitabine, oxaliplatin, bevacizumab, and dasatinib given in combination to subjects with advanced solid tumors. This will occur in the first part of the study (Phase I). Once this dose has been determined, it will be given to subjects with advanced metastatic colorectal cancer in the second part of the study (Phase II).

By giving these drugs in combination, researchers hope to evaluate the side effects of the study drugs in both groups, and to determine if this combination could possibly decrease or stabilize the cancer being treated.

Read more

Subjects will be enrolled at Duke University Medical Center (DUMC) and Rocky Mountain Cancer Center.

After satisfying eligibility and screening criteria, patients will be treated on 21 day cycles.

ABOUT THE STUDY DRUGS

  • Capecitabine (Xeloda™) is an oral (taken by mouth) chemotherapy drug in tablet form made by Roche Laboratories Inc. Capecitabine has been approved for use by the Food and Drug Administration (FDA) for first line treatment (treatment that should be used for cancer that has not been treated yet) of metastatic colorectal cancer and also for metastatic breast cancer.
  • Oxaliplatin (Eloxatin™) is an intravenous (given by injection into a vein) chemotherapy drug made by Sanofi-Synthélabo. This drug is also approved by the FDA for use in metastatic colorectal cancer.
  • Bevacizumab (Avastin™) is a type of intravenous cancer treatment called anti-angiogenic therapy (a type of therapy to treat cancer that interferes with blood flow to the tumor, thereby stopping tumor growth, and possibly leading to tumor shrinkage) made by Genentech Inc. Bevacizumab is approved by the FDA for first line treatment of metastatic colorectal cancer in combination with other chemotherapy.
  • Dasatinib (Sprycel™) is an oral drug made by Bristol Myers Squib, Inc (BMS). Dasatinib is approved by the FDA for the treatment of chronic myeloid leukemia (CML), acute lymphoblastic leukemia or for patients that are resistant to a medicine called imatinib mesylate (Gleevec™ ).
Keywords
Phase I, Solid Tumor, Colorectal, Dasatinib, Sprycel, Bevacizumab, Avastin, Oxaliplatin, Eloxatin, Capecitabine, Xeloda, Duke, Any Solid Tumor (Phase I), Metastatic Colorectal Cancer (Expanded Cohort)
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dasatinibDrug

    Also called Sprycel

    dasatinib at 50 mg PO BID)

  • bevacizumabDrug

    Also called Avastin

    7.5 mg/kg IV day 1

  • OxaliplatinDrug

    Also called Eloxatin

    130 mg/m2 IV day 1

  • CapecitabineDrug

    Also called Xeloda

    850 mg/m2 PO BID on days 1-14

Study groups in NCT00920868
Study groupRoleWhat they receive
Dasatinib 50mgExperimentalCohort 1
Receives: Drug: dasatinib; Drug: bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the maximum tolerated dose(MTD)/recommended phase II dose (RPTD) of capecitabine/oxaliplatin/bevacizumab/dasatinib for patients with advanced solid tumors.

    Measured: 9 months

Secondary outcomes (3)

  1. To further describe dose-limiting and non-dose-limiting toxicities associated with this regimen.

    Measured: 12 months

  2. To describe clinical activity (partial response (PR), complete response (CR) or stable disease (SD)>6 months, time to progression, and overall survival) associated with this regimen for patients with previously untreated metastatic and/or re

    Measured: 2 years

  3. To explore any correlation between blood, urine, and paraffin biomarkers and clinical outcomes

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionMay 2010
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00920868
Sponsor's protocol ID
Pro00010354
Acronym
XAD
Status last verified
Feb 2016
First submitted
10 Jun 2009
Last updated
3 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Strickler JH, McCall S, Nixon AB, Brady JC, Pang H, Rushing C, Cohn A, Starodub A, Arrowood C, Haley S, Meadows KL, Morse MA, Uronis HE, Blobe GC, Hsu SD, Zafar SY, Hurwitz HI. Phase I study of dasatinib in combination with capecitabine, oxaliplatin and bevacizumab followed by an expanded cohort in previously untreated metastatic colorectal cancer. Invest New Drugs. 2014 Apr;32(2):330-9. doi: 10.1007/s10637-013-0042-9. Epub 2013 Nov 1.

    PubMed 24173967

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing dasatinib, bevacizumab and Oxaliplatin in people with Solid Tumor and Metastatic Colorectal Cancer, run by Herbert Hurwitz, MD at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the maximum tolerated dose(MTD)/recommended phase II dose (RPTD) of capecitabine/oxaliplatin/bevacizumab/dasatinib for patients with advanced solid tumors. (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00920868, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.

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