Monoclonal Antibody Plus Chemotherapy in Treating Patients With Advanced Colorectal Cancer That Overexpresses HER2

NCT00003995 | Completed Phase 2

• 4 other identifiers: NCI-2012-02307PCI-98-056NCI-T98-0078CDR0000067205
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 5

Brief Summary

Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab and chemotherapy with irinotecan in treating patients who have stage IV colorectal cancer that overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive a loading dose of trastuzumab IV over 90 minutes on week 1, and over 30-90 minutes weekly thereafter. Patients receive irinotecan IV over 90 minutes following trastuzumab weekly for 4 weeks. Courses are repeated every 6 weeks in the absence of disease progression or unacceptable toxicity.

Biological: trastuzumab; Drug: irinotecan hydrochloride

Interventions

trastuzumab BIOLOGICAL

Arm I

irinotecan hydrochloride DRUG

Arm I

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed stage IV colorectal cancer with p185 HER2 overexpression * Bidimensionally measurable disease Indicator lesion must be outside of irradiated field No symptomatic CNS brain metastases PATIENT CHARACTERISTICS: * Performance status: ECOG 0-2 * Absolute granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT no greater than 3.0 times ULN * Creatinine no greater than 2.0 mg/dL * LVEF at least 45% by MUGA or ECHO * No myocardial infarction within the past 6 months * No congestive heart failure * No unstable angina * No clinically significant pericardial effusion or arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study * No other prior malignancy within the past 5 years, except: * Curatively treated basal or squamous cell skin cancer * Curatively treated carcinoma in situ of the cervix * No active serious infection or serious underlying medical condition that would prevent compliance * No dementia or significantly altered mental status PRIOR CONCURRENT THERAPY: * Concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa allowed * No prior trastuzumab * No more than 1 prior chemotherapy regimen for advanced disease (if progressed during or within 6 months of adjuvant therapy considered to have had 1 regimen for advanced disease) * No prior irinotecan * Concurrent contraception, estrogen replacement therapy, or megestrol acetate for anorexia allowed * Greater than 3 weeks since prior radiotherapy and recovered * Greater than 3 weeks since major surgery (except simple biopsy or venous access placement) and recovered * At least 3 weeks since prior investigational nonneoplastic drugs

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (5)

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Lifespan: The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Sarah Cannon-Minnie Pearl Cancer Center

Nashville, Tennessee, 37203, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Ramanathan RK, Hwang JJ, Zamboni WC, Sinicrope FA, Safran H, Wong MK, Earle M, Brufsky A, Evans T, Troetschel M, Walko C, Day R, Chen HX, Finkelstein S. Low overexpression of HER-2/neu in advanced colorectal cancer limits the usefulness of trastuzumab (Herceptin) and irinotecan as therapy. A phase II trial. Cancer Invest. 2004;22(6):858-65. doi: 10.1081/cnv-200039645.

  PMID: 15641483 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Trastuzumab; 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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Ramesh K. Ramanathan, MD

  University of Pittsburgh

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: June 25, 2004
• Study Start: September 1, 1999
• Primary Completion: March 1, 2006
• Last Updated: February 8, 2013

Record last verified: 2007-06

Locations

US (5)