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Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00230399
First received: September 9, 2005
Last updated: April 29, 2008
Last verified: April 2008
  Purpose

This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.


Condition Intervention Phase
Colorectal Cancer
Drug: Celecoxib
Drug: Capecitabine
Drug: Irinotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: C-2424: Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • To determine the objective response rate to the combination of celecoxib, capecitabine, and irinotecan in patients with metastatic colorectal cancer.

Secondary Outcome Measures:
  • To evaluate the time to progression of metastatic colorectal cancer after treatment with celecoxib, capecitabine, and irinotecan.

Estimated Enrollment: 15
Study Start Date: June 2003
Estimated Study Completion Date: March 2008
Estimated Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must have a histologically proven adenocarcinoma of colon or rectum with metastases or local recurrence.
  2. Patients must have at least one measurable lesion according to the RECIST criteria. Bone metastases, ascites and pleural effusion are not measurable.
  3. Minimum indicator lesion size as follows:

    Greater than or equal to 20 mm measured by conventional CT Greater than or equal to 10 mm measured by spiral techniques

  4. Prior use of celecoxib for the treatment of nonmalignant disorders is allowed.
  5. Patients must have a performance status of 0,1, or 2 by the Southwest Oncology Group criteria.
  6. Patients must have a calculated creatinine clearance of greater than 50 ml/min.
  7. Patients must have an absolute neutrophil count of greater than or equal to 1500/ml, platelet count greater than or equal to 100,000/ml, and total serum bilirubin equal or less than the institution's upper limit or normal range.
  8. Patients must have recovered from any effects of surgery.
  9. Evaluable disease must be present outside radiation field. At least 3 weeks must have elapsed after discontinuation of radiation therapy.
  10. Patients must provide a signed consent to participate in the study.

Exclusion Criteria:

  1. Patients with a proven history of peptic ulcer disease or gastroesophageal reflux.
  2. Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs.
  3. Patients who have received prior chemotherapy for colorectal cancer (including capecitabine or irinotecan) except for patients relapsing more than 6 months after completion of adjuvant chemotherapy.
  4. History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
  5. Unresolved bacterial infection requiring treatment with antibiotics.
  6. Pregnant or lactating women may not participate in the study. Women/men of reproductive age group may not participate unless they have agreed to use an effective method of contraception.
  7. Patients who have allergy to any of the study drugs or sulfa drugs.
  8. Patients known to have HIV-1 virus infection because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.
  9. Gilbert's disease.
  10. Lack of physical integrity of the upper gastrointestinal tract. Inability to swallow tablets or those who have malabsorption syndrome.
  11. Other serious concurrent infection
  12. Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230399

Locations
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Mark Zalupski, M.D. University of Michigan Cancer Center
  More Information

No publications provided

Responsible Party: Dr. Mark Zalupski, University of Michigan Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00230399     History of Changes
Other Study ID Numbers: UMCC 3-24
Study First Received: September 9, 2005
Last Updated: April 29, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Capecitabine
Celecoxib
Irinotecan
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014