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Home > "E" Clinical Trials Conditions > Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer  Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
For Condition: Stage 4 rectal cancer,stage 4 colon cancer,adenocarcinoma of the colon,adenocarcinoma of the rectum,recurrent colon cancer,recurrent rectal cancer
Status: No longer recruiting
Sponsor(s): Princess Margaret Hospital , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or metastatic colorectal cancer.
Details: OBJECTIVES: - Determine the efficacy of erlotinib, in terms of response rate and duration of stable disease, in patients with recurrent or metastatic colorectal cancer. - Determine the toxicity of this drug in these patients. - Determine the time to progression and response duration in patients treated with this drug. - Determine the relationships between clinical, pharmacokinetic, and pharmacodynamic effects of this drug in these patients. - Correlate baseline and post-treatment levels of epidermal growth factor receptor, its downstream signaling components, markers of angiogenesis, and apoptosis in tumor and skin biopsies with clinical outcome in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral erlotinib once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after CR is confirmed. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 4-8 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not curable with conventional therapy - Recurrent or metastatic disease - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - Target lesion must not be in a previously irradiated field unless progression of this lesion has been documented - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - More than 3 months Hematopoietic: - WBC at least 1,500/mm^3 - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - AST or ALT no greater than 3 times ULN (5 times ULN if liver metastases present) Renal: - Creatinine no greater than 1.25 times ULN OR - Creatinine clearance at least 50 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Gastrointestinal: - No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation - No active peptic ulcer disease - No unresolved complete or subacute bowel obstruction - No severe enteropathy that would interfere with absorption of study drug Ophthalmic: - No abnormalities of the cornea: - Dry eye syndrome or Sjogren's syndrome - Congenital abnormality (e.g., Fuch's dystrophy) - Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) - Abnormal corneal sensitivity test (Schirmer test or similar tear production test) Other: - No significant traumatic injury within the past 21 days - No ongoing or active infection - No psychiatric illness or social situation that would preclude study - No other concurrent uncontrolled illness that would preclude study - No other malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No more than 1 prior chemotherapy regimen for metastatic disease with either fluorouracil (5-FU) and oxaliplatin or 5-FU and a topoisomerase inhibitor (e.g., irinotecan), OR 5-FU (or other single-agent fluoropyrimidine, such as capecitabine) followed by irinotecan for advanced disease - Prior adjuvant chemotherapy allowed - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered Surgery: - At least 3 weeks since prior major surgery - No prior surgical procedures affecting absorption Other: - No prior epidermal growth factor receptor-targeting therapy - No other concurrent investigational therapies - No other concurrent anticancer therapy - No concurrent combination anti-retroviral therapy for HIV-positive patients - No concurrent warfarin - Low molecular weight heparin allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AmitOza, Study Chair, Princess Margaret Hospital
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Additional Information:
Study ID Numbers: CDR0000069258; NCI-5378,PMH-PHL-003
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032110
Other Stage 4 Rectal Cancer Studies:
1. Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
2. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer
3. FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen
4. Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
5. Combination Chemotherapy in Treating Patients With Colorectal Cancer
Related Studies:
Other Stage 4 rectal cancer Clinical Trials
Other Ontario Clinical Trials
Other London Clinical Trials
Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
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