Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer

NCT00022698 | Completed Phase 2 Results

• 1 other identifier: ML16323
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 17

Brief Summary

PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.

Conditions

Colorectal Cancer

Keywords

stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (1)

• Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0)

  Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as a greater than or equal to (\>/=) 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as reference the baseline sum of LD. Participants who did not have a post-baseline tumor measurement were considered non-responders in the assessment of ORR.

  Approximately 43 Months

Secondary Outcomes (8)

• Time to Disease Progression

  Approximately 43 Months

• Time to Treatment Failure

  Approximately 43 Months

• Percentage of Participants With One-year Survival

  Up to Month 12

• Overall Survival

  Approximately 43 Months

• Time To Objective Response

  Approximately 43 Months

Study Arms (2)

Cohort 1,Initial Regimen:(Capecitabine + Irinotecan )

EXPERIMENTAL

Participants will receive capecitabine (Xeloda) 1000 mg/m\^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m\^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who are responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).

Drug: Capecitabine; Drug: Irinotecan

Cohort 2,Amended Regimen:(Capecitabine + Irinotecan)

EXPERIMENTAL

Participants will receive capecitabine 900 mg/m\^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m\^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who will be responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).

Drug: Capecitabine; Drug: Irinotecan

Interventions

Capecitabine DRUG

Cohort 1,Initial Regimen:(Capecitabine + Irinotecan ); Cohort 2,Amended Regimen:(Capecitabine + Irinotecan)

Irinotecan DRUG

Cohort 1,Initial Regimen:(Capecitabine + Irinotecan ); Cohort 2,Amended Regimen:(Capecitabine + Irinotecan)

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma * At least 1 measurable lesion * At least 10 mm by spiral CT scan * At least 20 mm by conventional techniques * Bone metastases, ascites, or pleural effusions are not considered measurable disease * No evidence of CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 80-100% Life expectancy: * Not specified Hematopoietic: * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present or 10 times ULN if bone metastases present) * No known Gilbert's disease Renal: * Creatinine no greater than 1.5 times ULN * Creatinine clearance at least 50 mL/min Cardiovascular: * No clinically significant cardiac disease * No congestive heart failure * No symptomatic coronary artery disease * No cardiac arrhythmias uncontrolled with medication * No myocardial infarction within the past 12 months Gastrointestinal: * Able to swallow tablets * No lack of physical integrity of the upper gastrointestinal tract * No malabsorption syndrome Other: * No prior unanticipated severe reaction to fluoropyrimidine therapy * No hypersensitivity to fluorouracil * No history of uncontrolled seizures or CNS disorders * No psychological illness or condition that would preclude study entry * No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * No serious infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 12 months since prior neoadjuvant or adjuvant, active or passive immunotherapy * No concurrent active or passive immunotherapy (e.g., 17-1A antibody) for colon cancer * No concurrent prophylactic hematopoietic growth factors Chemotherapy: * At least 12 months since prior neoadjuvant or adjuvant cytotoxic chemotherapy * No prior chemotherapy for metastatic colorectal cancer * No prior therapy with irinotecan or capecitabine * No other concurrent cytotoxic agents Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy * No prior radiotherapy to measurable lesion (newly arising lesions in a previously irradiated area allowed) * No concurrent radiotherapy Surgery: * At least 4 weeks since prior major surgery and recovered * No prior organ allograft Other: * At least 4 weeks since prior participation in an investigational drug study * No other concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (17)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Lombardi Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0084, United States

Location

St. Louis University Hospital Cancer Center

St Louis, Missouri, 63110-0250, United States

Location

HemOnCare, P.C.

Brooklyn, New York, 11235, United States

Location

Lincoln Medical and Mental Health Center

The Bronx, New York, 10451, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Charleston Hematology-Oncology, P.A.

Charleston, South Carolina, 29403, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98104, United States

Location

Rockwood Clinic P.S.

Spokane, Washington, 99202, United States

Location

West Virginia University Hospitals

Morgantown, West Virginia, 26506-9300, United States

Location

Related Publications (2)

• Meropol NJ, Gold PJ, Diasio RB, Andria M, Dhami M, Godfrey T, Kovatich AJ, Lund KA, Mitchell E, Schwarting R. Thymidine phosphorylase expression is associated with response to capecitabine plus irinotecan in patients with metastatic colorectal cancer. J Clin Oncol. 2006 Sep 1;24(25):4069-77. doi: 10.1200/JCO.2005.05.2084.

  PMID: 16943524 RESULT

• Carlini LE, Meropol NJ, Bever J, Andria ML, Hill T, Gold P, Rogatko A, Wang H, Blanchard RL. UGT1A7 and UGT1A9 polymorphisms predict response and toxicity in colorectal cancer patients treated with capecitabine/irinotecan. Clin Cancer Res. 2005 Feb 1;11(3):1226-36.

  PMID: 15709193 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Capecitabine; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: January 27, 2003
• Study Start: May 1, 2001
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: April 15, 2016
• Results First Posted: April 15, 2016

Record last verified: 2005-02

Locations

US (17)