Clinical trial · Interventional
Monoclonal Antibody Plus Chemotherapy in Treating Patients With Advanced Colorectal Cancer That Overexpresses HER2
Phase II and Pharmacokinetic Study of CPT-11 and Trastuzumab (RhuMab HER2, Herceptin) in Advanced Colo-Rectal Cancer With p185 HER 2 Overexpression
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Biological: trastuzumab
- Drug: irinotecan hydrochloride
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- RESULTRamanathan 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