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AdenocarcinomaPhase 2NCT00127036

Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A)

A Phase 2 study testing XELOX, XELIRI and Bevacizumab in people with Adenocarcinoma and Colon Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to determine if the investigators can predict the sensitivity or resistance of colon cancer to the two available first line chemotherapy agents. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenocarcinoma, Colon Cancer
What is being tested?
XELOX, XELIRI and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
12 sitesUnited States
Study dates
Oct 2003to Dec 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patients with metastatic, Response Evaluation Criteria In Solid Tumors (RECIST) measurable, adenocarcinoma of the colon and/or rectum are eligible provided their disease is metastatic to the liver. The liver metastatic disease should be confirmed cytologically or histologically at the time of study biopsy or prior to the study biopsy. All pre-study scans documenting disease must be done < 4 weeks prior to registration.
  • Patients must have had no prior treatment with either irinotecan or oxaliplatin.
  • Prior adjuvant therapy with fluoropyrimidine is allowed.
  • Prior radiotherapy is allowed, but patients should have measurable disease outside the radiation port and/or progressive disease within the previously radiated volume. In addition, it must be at least 2 weeks since administration of radiation therapy and all signs of toxicity must have abated.
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  • Patients must have adequate renal and hepatic function (creatinine < 1.6 and calculated creatinine clearance [Cockcroft-Gault equation] > 60 ml/min; bilirubin < 2.0; and serum glutamic oxaloacetic transaminase [SGOT] less than 3 x normal limits) obtained within 4 weeks prior to registration.
  • Alkaline phosphatase < 2.5 x upper normal limit (or < 5 x upper normal limit in the case of liver metastases or < 10 x upper normal limit in the case of bone disease)
  • Patients must have absolute neutrophil count (ANC) > 1500/mm³ and platelet count > 100,000/mm³ within 4 weeks prior to registration.
  • Have a negative serum or urine pregnancy test within 7 days prior to starting therapy (female patients of childbearing potential)

Who cannot join

  • Pregnant and breast-feeding women are excluded from the study because effects on the fetus are unknown and there may be a risk of increased fetal wastage.
  • Women of childbearing potential with either a positive or no pregnancy test (serum or urine) at baseline. Women/men of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.) Patients will agree to continue contraception for 30 days from the date of the last study drug administration.
  • Serious, uncontrolled, concurrent infection(s). Patients must have no evidence of significant active infection (e.g., pneumonia, peritonitis, wound abscess, etc.) at time of study entry.
  • Life expectancy < 3 months
  • Any prior fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 6 months earlier)
  • Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase (DPD) deficiency
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  • Treatment for other carcinomas within the last 5 years, except cured non-melanoma skin and treated in-situ cervical cancer
  • Participation in any investigational drug study
  • Clinically significant cardiac disease of New York Heart Association Class III or greater (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
  • Evidence of central nervous system (CNS) metastases (unless CNS metastases have been stable for > 3 months) or history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.
  • Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
  • Major surgery, open biopsy, or significant trauma injury within 28 days prior to Day 0
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  • Known, existing uncontrolled coagulopathy
  • Impaired renal function (estimated creatinine clearance < 60ml/min as calculated with Cockcroft-Gault equation
  • Unwillingness to give written informed consent
  • Unwillingness to participate or inability to comply with the protocol for the duration of the study
  • Urine protein: creatinine ratio > 1.0 at screening
  • Blood pressure of > 150/100 mmHg
  • Unstable angina
  • Clinically significant peripheral vascular disease
  • Arterial thrombotic events, stroke or transient ischemic attack (TIA) within the last 6 months

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • North Broward Medical Center

    Deerfield Beach, Florida, 33064

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • Center for Cancer Care & Research - Watson Clinic

    Lakeland, Florida, 33805

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • Fawcett Memorial Hospital

    Port Charlotte, Florida, 33592

  • St. Joseph's Candler Health System

    Savannah, Georgia, 31405

  • Martin Memorial

    Stuart, Florida, 34994

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Bay Area Oncology

    Tampa, Florida, 33607

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

  • Space Coast Medical Associates

    Titusville, Florida, 32796

Other trials in United States

About this study

Official title: A Multicenter Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A)

The purpose of this study is to determine if the investigators can predict the sensitivity or resistance of colon cancer to the two available first line chemotherapy agents.

Read the detailed description

Colorectal cancer is the third largest cause of cancer mortality in the United States. The treatment of metastatic colorectal cancer is undergoing rapid improvement. Currently, there are two major chemotherapy regimens, which can both be combined with anti-angiogenesis treatment. These regimens are 5-Fluorouracil (5-FU) + irinotecan and 5-FU + oxaliplatin. Each therapy has roughly similar rates of response, but it is unclear which specific therapy would benefit which patients. The advent of genome wide expression analysis provides a tool to analyze these differences. In the microarray analysis of colon cancer outcome trial, sponsored by the National Institutes of Health (NIH) and Moffitt Cancer Center, patients with newly diagnosed metastatic colon cancer are biopsied and samples are preserved in ribonucleic acid (RNA) later. Patients are then randomized to either one of two state of the art regimens: capecitabine + irinotecan + avastin (bevacizumab) or capecitabine + oxaliplatin + avastin. Response to chemotherapy, time to progression, and overall survival are end points of this trial. Once accrual of patients has been met, the investigators will compare genome wide expression patterns for each group.

Being tested
XELOX, XELIRI, Bevacizumab
Keywords
colon, adenocarcinoma, adenocarcinoma-colon, adenocarcinoma-rectum
Medical subject headings
Adenocarcinoma, Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

  • XELOXDrug

    Also called Oxaliplatin and Capecitabine

    XELOX: Oxaliplatin 130 mg/m^2 intravenously (IV); Capecitabine 825 mg/m^2 by mouth (po)

  • XELIRIDrug

    Also called Irinotecan and Capecitabine

    XELIRI: Irinotecan 240 mg/m^2 IV; Capecitabine 825 mg/m^2 by mouth (po)

  • BevacizumabDrug

    Also called Avastin®

    7.5 mg/kg intravenously (IV)

Study groups in NCT00127036
Study groupRoleWhat they receive
XELOX + BevacizumabExperimentalArm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
Receives: Drug: XELOX; Drug: Bevacizumab
XELIRI + BevacizumabExperimentalArm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
Receives: Drug: XELIRI; Drug: Bevacizumab

What is being measured

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

  1. Number of Participants Per Treatment Arm, Per Tumor Tissue Response Classifier

    Investigators would develop tumor tissue classifiers to predict response to the XELOX arm or XELIRI arm; with gene expression profiles on 75 patients on each of 2 arms, construct 2 classifiers to distinguish responders (complete responses, partial responses, stable disease) from non-responders (progressive disease).

    Measured: 30 Days After End of Treatment - Average of 6 Months

Secondary outcomes (2)

  1. Number of Participants Per Treatment Arm, With Overall Survival (OS)

    Investigators planned to evaluate the overall survival of colorectal cancer (CRC) patients treated with XELOX + bevacizumab (Arm A) or XELIRI + bevacizumab (Arm B).

    Measured: 30 Days After End of Treatment - Average of 6 Months

  2. Number of Participants With Serious Adverse Events (SAEs)

    Review of Serious Adverse Events (SAEs) To assess the toxicity associated with Arms A and B. Response rates and toxicity rates for each arm were to be estimated and exact (using Casella's method) 95% confidence intervals for those proportions computed. With the anticipated 75 patients in each arm, these estimated proportions would have standard errors not exceeding 7%.

    Measured: 30 Days After End of Treatment - Average of 6 Months

Timeline

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

  1. First posted5 Aug 2005 (estimated)
  2. Study startOct 2003
  3. Primary completionDec 2010
  4. Study completionDec 2010

Why it stopped: drug now on market

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00127036
Sponsor's protocol ID
MCC-13449
Other IDs
R21 CA10135, XEL390, 2005-0729
Status last verified
Dec 2011
First submitted
3 Aug 2005
Last updated
23 Mar 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XELOX, XELIRI and Bevacizumab in people with Adenocarcinoma and Colon Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 12 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 10 inclusion and 22 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: stopped early, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

Yes. Results are posted in the registry (first posted 5 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Per Treatment Arm, Per Tumor Tissue Response Classifier (time frame: 30 Days After End of Treatment - Average of 6 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 NCT00127036.

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 23 Mar 2017.

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