Trial Search Results

Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy

RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and ramucirumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab and ramucirumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet know whether giving cetuximab and irinotecan hydrochloride together is more effective with or without ramucirumab in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying the side effects and how well giving cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Biological: cetuximab
  • Biological: ramucirumab
  • Drug: irinotecan hydrochloride

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Measurable disease

   - Histologically confirmed adenocarcinoma of the colon or rectum

   - K-ras wild type based on either primary or metastatic tumor

   - Must have received prior first-line therapy comprising oxaliplatin-based
   fluoropyrimidine-containing chemotherapy and bevacizumab for metastatic colorectal
   cancer

   - Registration within 42 days since confirmed disease progression

   - Performance status 0-1

   - ANC ≥ 1,500/μL

   - Platelet count ≥ 75,000/μL

   - Hemoglobin ≥ 9 g/dL

   - Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 40
   mL/min

   - Urine protein ≤ 1+ on dipstick or routine urinalysis (if ≥ 2+, a 24-hour urine
   collection must demonstrate < 1,000 mg of protein)

   - Total bilirubin ≤ 2.0 mg/dL

   - AST and ALT ≤ 3.0 times ULN (5.0 times ULN for patients with liver metastases)

   - INR ≤ 1.6 (≤ 3.0 for patients on warfarin and no active bleeding [i.e., no bleeding
   within the past 14 days])

   - Negative pregnancy test

   - Fertile patients must use effective contraception during and for 3 months after
   completion of study therapy

   - At least 28 days and no more than 90 days since prior bevacizumab

   - Concurrent stable dose of oral anticoagulant or low-molecular weight heparin allowed

Exclusion Criteria:

   - Brain or CNS metastases

   - Pregnant or nursing

   - Prior therapy with drugs other than oxaliplatin and a fluoropyrimidine plus
   bevacizumab for colorectal cancer

   - Clinically significant (equivalent to NCI CTCAE grade 3-4) bleeding episodes within
   the past 3 months

   - Active infection

   - Symptomatic congestive heart failure

   - Unstable angina pectoris

   - Symptomatic or poorly controlled cardiac arrhythmia

   - Uncontrolled thrombotic or hemorrhagic disorder

   - Uncontrolled or poorly controlled hypertension despite standard medical management
   (e.g., consistently systolic BP > 160 mm Hg and diastolic BP > 90 mm Hg)

   - Acute arterial thrombotic events within the past 6 months, including cerebrovascular
   accident, transient ischemic attack, myocardial infarction, or unstable angina

   - Other cancer requiring therapy within the past 3 years except in situ carcinoma or
   nonmelanoma skin cancer

   - Acute or subacute intestinal obstruction

   - History of inflammatory bowel disease requiring pharmacological and/or surgical
   intervention within the past 12 months

   - Known allergy to any of the treatment components

   - Major surgery within the past 28 days

   - Subcutaneous venous access device placement within the past 7 days

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting