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Colorectal CancerPhase 2NCT00118105

S0408: Capecitabine, Oxaliplatin, and Bevacizumab in Pts Undergoing Surgery for Liver Mets From Colorectal Cancer

A Phase 2 study testing bevacizumab, capecitabine and oxaliplatin in people with Colorectal Cancer and Metastatic Cancer, run by SWOG Cancer Research Network at 46 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Metastatic Cancer
What is being tested?
bevacizumab, capecitabine and oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
46 sitesUnited States
Study dates
Nov 2006to Apr 2007
Phase
Phase 2
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

DISEASE CHARACTERISTICS:

  • Diagnosis of hepatic metastases secondary to colorectal cancer by percutaneous hepatic biopsy
  • Resectable hepatic metastases by any of the following:
  • Minor resection (i.e., less than a hemihepatectomy)
  • Major resection (i.e., hemihepatectomy or extended hepatectomy)
  • Bilobar resection (including atypical resection)
  • Synchronous primary tumor and hepatic metastases allowed
  • Radiologic evidence of hepatic metastases by multiphasic contrast-enhanced spiral CT scan
  • Resectable primary colorectal cancer that is in place allowed
  • Measurable disease
  • No evidence of extrahepatic metastases by chest x-ray or CT scan of the chest

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Hemoglobin ≥ 9.0 g/dL
  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • SGOT or SGPT ≤ 2.5 times ULN

Renal

  • Creatinine clearance ≥ 60 mL/min
  • Urine protein/creatinine ratio < 1 OR
  • Urine protein < 1 g by 24-hour urine collection

Cardiovascular

  • No uncontrolled hypertension (i.e., blood pressure > 150/90 mm Hg)
  • History of hypertension allowed provided it is well controlled on a stable regimen of anti-hypertensive therapy
  • No arterial thromboembolic event within the past 12 months, including any of the following:
  • Transient ischemic attack
  • Cerebrovascular accident
  • Unstable angina
  • Myocardial infarction
  • No peripheral vascular disease ≥ grade 2

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No pre-existing peripheral neuropathy ≥ grade 2
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 6 months since prior adjuvant chemotherapy for the primary tumor
  • No prior systemic chemotherapy for metastatic disease
  • No prior hepatic artery infusion chemotherapy for metastatic disease

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy for metastatic disease

Surgery

  • More than 7 days since prior colonoscopy or fine needle aspiration
  • More than 28 days since prior major invasive surgery or open biopsy

Other

  • At least 4 weeks since prior and no concurrent sorivudine or brivudine
  • No prior radiofrequency ablation for metastatic disease
  • No prior cryotherapy for metastatic disease
  • No other prior ablative techniques for metastatic disease
  • No concurrent cimetidine
  • Concurrent ranitidine or other drug from a different antiulcer class allowed
  • No concurrent oral anticoagulation for treatment of thrombosis
  • Concurrent warfarin (1 mg) to maintain patency of central venous catheter allowed

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

United States46 sites

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • Billings Clinic Cancer Center

    Billings, Montana, 59107-5100

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • St. James Community Hospital

    Butte, Montana, 59701

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Frontier Cancer Center

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazooaa, Michigan, 49001

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Reid Hospital & Health Care Services, Incorporated

    Richmond, Indiana, 47374

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: A Phase II Trial of Neoadjuvant Capecitabine, Oxaliplatin, and Bevacizumab for Resectable Colorectal Metastases in the Liver

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab before and after surgery may be an effective treatment for liver metastases.

PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with bevacizumab works in treating patients who are undergoing surgery for liver metastases due to colorectal cancer.

Read the detailed description

OBJECTIVES:

  • Determine the proportion of patients with resectable hepatic metastases secondary to colorectal cancer who undergo surgical resection and achieve a R0 resection after treatment with neoadjuvant capecitabine, oxaliplatin, and bevacizumab.
  • Determine the probability of non-progression (i.e., stable disease or response [complete and partial, confirmed and unconfirmed]) in patients treated with this regimen.
  • Compare the proportion of patients treated with this regimen who undergo surgical resection and those who achieve a R0 resection with that described in the literature.
  • Determine overall survival and disease-free survival of patients treated with this regimen.
  • Determine response by positron emission tomography in patients treated with this regimen.
  • Correlate clinical outcome with expression of biomarkers (e.g., thymidylate synthase, dihydropyrimidine dehydrogenase, thymidine phosphorylase, excision repair cross complementing 1, and hTERT) and telomere length in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Neoadjuvant therapy: Patients receive bevacizumab* IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Bevacizumab is administered during courses 1-3 of neoadjuvant therapy.

  • Surgery: Approximately 3-4 weeks after completion of neoadjuvant therapy, patients are evaluated. Patients with unresectable disease are removed from the study. Patients with resectable disease undergo surgical resection of liver metastases within 4-6 weeks after completion of neoadjuvant therapy.
  • Adjuvant therapy: Beginning at least 28 days after surgical resection, patients with at least stable disease after completion of neoadjuvant therapy receive 4 courses of adjuvant bevacizumab**, oxaliplatin, and capecitabine as in neoadjuvant therapy.

NOTE: **Bevacizumab is administered during courses 1-4 of adjuvant therapy.

After completion of study treatment, patients are followed every 4 months until disease progression and then every 6 months for up to 3 years from study entry.

PROJECTED ACCRUAL: Approximately 35-65 patients will be accrued for this study.

Keywords
recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer, liver metastases
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

  • bevacizumabBiological

    Also called Avastin, NSC-704865

    Preoperative: 7.5 mg/kg, IV, Day 1 of cycles 1,2,3 Postoperative: 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4

  • capecitabineDrug

    Also called Xeloda, NSC-712807

    Pre \& Post Operative: 1,700 mg/m^2/day, PO at 12 hr interval, Days 1-14 of cycles 1,2,3,4

  • oxaliplatinDrug

    Also called NSC-266046

    130 mg/m^2, IV, Day 1 of cycles 1,2,3,4

  • conventional surgeryProcedure or surgery

    Resection

Study groups in NCT00118105
Study groupRoleWhat they receive
Chemotherapy + Surgery + ChemotherapyExperimentalPreoperative Neoadjuvant Chemotherapy * Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3 * Oxaliplatin, 130 mg/m^2, IV, Day 1 of cycles 1,2,3,4 * Capecitabine, 1,700 mg/m^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4 Conventional surgery: After 4 cycles of chemotherapy Postoperative Neoadjuvant Chemotherapy * Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4 * Oxaliplatin, 130 mg/m^2, IV, Day 1 of cycles 1,2,3,4 * Capecitabine, 1,700 mg/m^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4
Receives: Biological: bevacizumab; Drug: capecitabine; Drug: oxaliplatin; Procedure: conventional surgery

What is being measured

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

  1. Proportion of patients with R0 resection after treatment

    Measured: 16-18 weeks from registration

  2. Probability of nonprogression (i.e., stable disease or response [complete and partial, confirmed and unconfirmed])

    Measured: 12 weeks from registration

  3. Comparison of patients achieving R0 resection with literature

    Measured: 16-18 weeks from registration

  4. Overall survival

    Measured: Up to 3 years

  5. Disease-free survival

    Measured: Up to 3 years

  6. Positron emission tomography response

    Measured: Registration and 12 weeks

  7. Correlation of clinical outcome with expression of biomarkers and telomere length

    Measured: Up to 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 posted11 Jul 2005 (estimated)
  2. Study startNov 2006
  3. Primary completionApr 2007
  4. Study completionApr 2007

Why it stopped: Budget Constraints

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00118105
Sponsor's protocol ID
CDR0000433491
Other IDs
S0408, U10CA032102
Status last verified
Jan 2013
First submitted
8 Jul 2005
Last updated
3 Jan 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Abdalla EK, Eng C, Madary A, Vauthey JN; Southwest Oncology Group 0408. Southwest Oncology Group 0408: Phase II trial of neoadjuvant capecitabine/oxaliplatin/bevacizumab for resectable colorectal metastases in the liver. Clin Colorectal Cancer. 2006 Mar;5(6):436-9. doi: 10.3816/ccc.2006.n.015. No abstract available.

    PubMed 16635283

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, capecitabine and oxaliplatin in people with Colorectal Cancer and Metastatic Cancer, run by SWOG Cancer Research Network at 46 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?

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: withdrawn, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Proportion of patients with R0 resection after treatment (time frame: 16-18 weeks from registration). The study lists 7 primary outcomes in all. 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 NCT00118105, 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 Jan 2013.

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