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

NCT00127036 | Terminated Phase 2 Results DMC

• 4 other identifiers: MCC-13449R21 CA10135XEL3902005-0729
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Adenocarcinoma; Colon Cancer

Keywords

colon; adenocarcinoma; adenocarcinoma-colon; adenocarcinoma-rectum

Outcome Measures

Primary Outcomes (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).

  30 Days After End of Treatment - Average of 6 Months

Secondary Outcomes (2)

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

  30 Days After End of Treatment - Average of 6 Months

• Number of Participants With Serious Adverse Events (SAEs)

  30 Days After End of Treatment - Average of 6 Months

Study Arms (2)

XELOX + Bevacizumab

EXPERIMENTAL

Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression

Drug: XELOX; Drug: Bevacizumab

XELIRI + Bevacizumab

EXPERIMENTAL

Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression

Drug: XELIRI; Drug: Bevacizumab

Interventions

XELOX DRUG

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

Also known as: Oxaliplatin and Capecitabine

XELOX + Bevacizumab

XELIRI DRUG

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

Also known as: Irinotecan and Capecitabine

XELIRI + Bevacizumab

Bevacizumab DRUG

7.5 mg/kg intravenously (IV)

Also known as: Avastin®

XELIRI + Bevacizumab; XELOX + Bevacizumab

Eligibility Criteria

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

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Roche Pharma AG: collaborator

Study Sites (12)

North Broward Medical Center

Deerfield Beach, Florida, 33064, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33916, United States

Location

Center for Cancer Care & Research - Watson Clinic

Lakeland, Florida, 33805, United States

Location

Fawcett Memorial Hospital

Port Charlotte, Florida, 33592, United States

Location

Martin Memorial

Stuart, Florida, 34994, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Bay Area Oncology

Tampa, Florida, 33607, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Space Coast Medical Associates

Titusville, Florida, 32796, United States

Location

St. Joseph's Candler Health System

Savannah, Georgia, 31405, United States

Location

Southeast Nebraska Cancer Center

Lincoln, Nebraska, 68510, United States

Location

Related Links

• H. Lee Moffitt Cancer Center \& Research Institute Web Page

MeSH Terms

Conditions

Adenocarcinoma; Colonic Neoplasms; Rectal Neoplasms

Interventions

XELOX; Oxaliplatin; Capecitabine; Irinotecan; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Study was Terminated early, not Completed. Study Drug now on the market. Due to slow accrual, too few patients who had both clinical and microarray data to perform the proposed analysis. 65 of 92 patients consented were assigned to treatment arms.

Results Point of Contact

• Title: Jonathan Strosberg, M.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute

jonathan.strosberg@moffitt.org

813-745-2069

Study Officials

• Jonathan Strosberg, MD

  H. Lee Moffitt Cancer Center & Research Institute / University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 3, 2005
• First Posted: August 5, 2005
• Study Start: October 1, 2003
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 23, 2017
• Results First Posted: April 5, 2012

Record last verified: 2011-12

Locations

US (12)