Phase II and Pharmacokinetic Study of CPT-11 and Trastuzumab (RhuMab HER2, Herceptin) in Advanced Colo-Rectal Cancer With p185 HER 2 Overexpression
N/A
N/A
Both
Colorectal Cancer
Trial Information
Phase II and Pharmacokinetic Study of CPT-11 and Trastuzumab (RhuMab HER2, Herceptin) in Advanced Colo-Rectal Cancer With p185 HER 2 Overexpression
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Ramesh K. Ramanathan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Pittsburgh
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02307
NCT ID:
NCT00003995
Start Date:
September 1999
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage IV colon cancer
- stage IV rectal cancer
- recurrent colon cancer
- recurrent rectal cancer
- Rectal Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
| Sarah Cannon-Minnie Pearl Cancer Center | Nashville, Tennessee 37203 |
| Lifespan: The Miriam Hospital | Providence, Rhode Island 02906 |
