Monoclonal Antibody Plus Chemotherapy in Treating Patients With Advanced Colorectal Cancer That Overexpresses HER2
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00003995 |
Recruitment Status
:
Completed
First Posted
: June 25, 2004
Last Update Posted
: February 8, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Biological: trastuzumab Drug: irinotecan hydrochloride | Phase 2 |
OBJECTIVES:
I. Determine the objective response rate of irinotecan and trastuzumab in patients with stage IV colorectal cancer and p185 HER2 overexpression.
II. Evaluate the safety and toxic effects of this treatment regimen in these patients.
III. Determine the overall survival and time to progression in these patients in response to this treatment regimen.
IV. Determine the pharmacokinetics of trastuzumab in combination with irinotecan and antibodies to trastuzumab in these patients.
V. Determine the expression of HER2/neu in these patients.
OUTLINE: This is a multicenter study.
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.
Patients are followed every 3 months.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II and Pharmacokinetic Study of CPT-11 and Trastuzumab (RhuMab HER2, Herceptin) in Advanced Colo-Rectal Cancer With p185 HER 2 Overexpression |
Study Start Date : | September 1999 |
Actual Primary Completion Date : | March 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I
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 |

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003995
United States, New York | |
Albert Einstein Comprehensive Cancer Center | |
Bronx, New York, United States, 10461 | |
United States, Pennsylvania | |
University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Rhode Island | |
Lifespan: The Miriam Hospital | |
Providence, Rhode Island, United States, 02906 | |
United States, Tennessee | |
Sarah Cannon-Minnie Pearl Cancer Center | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Chair: | Ramesh K. Ramanathan, MD | University of Pittsburgh |
Publications of Results:
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003995 History of Changes |
Other Study ID Numbers: |
NCI-2012-02307 PCI-98-056 NCI-T98-0078 CDR0000067205 ( Registry Identifier: PDQ (Physician Data Query) ) |
First Posted: | June 25, 2004 Key Record Dates |
Last Update Posted: | February 8, 2013 |
Last Verified: | June 2007 |
Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
Additional relevant MeSH terms:
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Irinotecan Trastuzumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |