Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer

NCT00305643 | Terminated Phase 3 Results DMC

• 4 other identifiers: 2005-0328MDA-CCC-0326MDA-2005-0328CDR0000458042
• Study Type: interventional
• Target: 11
• Locations: 2 countries
• Sites: 14

Brief Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with capecitabine may kill more tumor cells. Celecoxib may prevent or lessen hand-foot syndrome caused by capecitabine. PURPOSE: This randomized phase III trial is studying how well celecoxib works in preventing hand/foot syndrome caused by capecitabine in patients with metastatic breast or colorectal cancer.

Conditions

Breast Cancer; Colorectal Cancer; Pain

Keywords

Hand-Foot Syndrome; cancer-related problem/condition; drug/agent toxicity by tissue/organ; pain; palmar-plantar erythrodysesthesia; stage IV breast cancer; male breast cancer; recurrent breast cancer; stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; Celecoxib; Celebrex; Capecitabine; Xeloda

Outcome Measures

Primary Outcomes (1)

• Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on the CTC 3.0 Criteria.

  The primary classification of palmar planter erythrodysethesia according to National Cancer Institute Common Toxicity Criteria (CTC) 3.0 criteria used to determine the incidences of \> grade 1 hand and foot syndrome (HFS) by 16 weeks from the commencement of therapy.

  At 16 Weeks, with evaluations and blood test every 3 weeks.

Secondary Outcomes (1)

• Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on WHO Criteria.

  At 16 Weeks

Study Arms (2)

Arm I: Celecoxib + Capecitabine

EXPERIMENTAL

Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day).

Drug: Capecitabine; Drug: Celecoxib; Procedure: Radiation Therapy

Arm II: Placebo + Capecitabine

PLACEBO COMPARATOR

Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day)

Drug: Capecitabine; Procedure: Radiation Therapy; Drug: Placebo

Interventions

Capecitabine DRUG

Initial dose of 750-1500 mg/m\^2 orally twice a day for each 21 day cycle.

Also known as: Xeloda

Arm I: Celecoxib + Capecitabine; Arm II: Placebo + Capecitabine

Celecoxib DRUG

200 mg given orally twice a day for each 21 day cycle.

Also known as: Celebrex

Arm I: Celecoxib + Capecitabine

Radiation Therapy PROCEDURE

Some patients may undergo radiation therapy 5 days a week for 5-6 weeks, and receive oral capecitabine twice daily 5 days a week. Following completion of radiotherapy, patients may continue oral capecitabine once daily on days 1-14.

Also known as: RT, XRT

Arm I: Celecoxib + Capecitabine; Arm II: Placebo + Capecitabine

Placebo DRUG

Oral placebo twice daily on days 1-21

Arm II: Placebo + Capecitabine

Eligibility Criteria

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

You may qualify if:

• Patients with metastatic colorectal cancer or breast cancer who are scheduled\*\*\* to receive capecitabine with an initial dose in the range of 750-1500 mg/m2\*\* twice daily (total daily dose in the range of 1500-3000 mg/m2) alone or in combination with one or more other agents. \*\*\*Patients may enter the study after having received capecitabine for up to 21 days prior to study entry. \*\*Doses may be rounded upward or downward per physician discretion to utilize 500mg tablets.
• Patients with either metastatic colorectal or metastatic breast cancer may have received any number or type of prior treatment regimens for metastatic disease or they may have received no prior treatment for metastatic disease.
• Men and women from all ethnic and racial groups.
• \>/= 18 years old
• Eastern Cooperative Oncology Group (ECOG) Performance Status \</= 2
• Adequate organ function: a. Total bilirubin \</= 1.5 \* the institutional upper-normal limits (IUNL) b. aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \</= 2.5 \* IUNL c. Patients with liver mets AST/(SGOT) and/or ALT(SGPT) \< 5 \* IUNL d. Alkaline phosphatase \</= 5 \* IUNL e. Creatinine Clearance \> 50 ml/min
• Adequate bone marrow function: (a) Leukocytes \>/= 3,000/microL; (b) Absolute neutrophil count \>/= 1,500/microL; (c) Platelets \>/= 100,000/microL
• Women of childbearing age and all men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
• Negative pregnancy test for women of childbearing age.
• Must have the ability to understand and the willingness to provide a written informed consent to participate in the study.
• Controlled brain metastasis (i.e. stereotactic surgery, surgery steroids, anticonvulsants).

You may not qualify if:

• History of allergies to sulfonamide, aspirin, any NSAID (Nonsteroidal anti-inflammatory drugs)or 5FU or any COX-2 inhibitor.
• Any regular use of COX-2 inhibitors, NSAIDS or aspirin \>325 mg more than twice a week.
• Pregnancy or lactation.
• History of significant neurological or psychiatric disorders that would impede giving consent, treatment or follow-up.
• Any serious illness or medical condition: uncontrolled congestive heart failure, uncontrolled hypertension or arrhythmia, active angina pectoris, any history of myocardial infarction, stroke or transient ischemic attack (TIA).
• Serious uncontrolled active infection.
• Patients who cannot comply with taking and documenting oral study medications.
• History of active peptic ulcer disease or upper gastrointestinal (GI) bleed within 12 months of enrollment.
• Use of warfarin.
• Patients with uncontrolled brain metastasis.
• Patients may have had prior Hand-foot syndrome (HFS) but it must be completely resolved for \>/= 4 weeks.
• No concurrent radiation therapy.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Pfizer: collaborator

Study Sites (14)

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Cancer Research for the Ozarks

Springfield, Missouri, 65804, United States

Location

Hematology Oncology Associates of Central New York, PC - Northeast Center

East Syracuse, New York, 13057-4510, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

CCOP - Main Line Health

Wynnewood, Pennsylvania, 19096, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Scott and White Cancer Institute

Temple, Texas, 76508, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

MBCCOP - San Juan

San Juan, 00936, Puerto Rico

Location

Related Links

• Clinical trial summary, the National Cancer Institute's PDQ® database
• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Pain; Hand-Foot Syndrome; Drug-Related Side Effects and Adverse Reactions; Breast Neoplasms, Male; Colonic Neoplasms; Rectal Neoplasms

Interventions

Capecitabine; Celecoxib; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Drug Eruptions; Dermatitis; Drug Hypersensitivity; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Therapeutics

Limitations and Caveats

Due to low accrual in this trial, no outcome measures were evaluable.

Results Point of Contact

• Title: Scott Kopetz, MD, PHD / Assistant Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Scott Kopetz, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 22, 2006
• Study Start: February 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 24, 2015
• Results First Posted: December 24, 2015

Record last verified: 2015-11

Locations

PR (1); US (13)