A PHASE II, SINGLE ARM STUDY OF CP-751,871 IN PATIENTS WITH REFRACTORY METASTATIC ADENOCARCINOMA OF THE COLON OR RECTUM
- Conditions
- Refractory colorectal cancerMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer
- Registration Number
- EUCTR2007-004787-49-GB
- Lead Sponsor
- Pfizer Inc - 235 East 42nd Street, New York, NY 10017
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
1.Age >18 years
2.Histologically or cytologically confirmed adenocarcinoma arising in the colon or rectum. Histological evaluation (new biopsy) at the time of enrollment is not required.
3.Radiographic evidence of metastatic, progressive disease following standard therapies. Patients in the United States will have been treated previously with, or have a significant known contraindication to, a fluoropyrimidine, irinotecan and oxaliplatin. These patients may or may not have been treated with bevacizumab (Avastin), cetuximab (Erbitux) and/or Panitumumab (Vectibix). Patients outside of the United States will have been treated with, or have a contraindication to, at least 2 prior chemotherapy regimens with whichever drugs are routinely used and available in standard practice in that country.
4.ECOG performance status 0-1.
5.At least three weeks since the last therapy regimen prior to enrollment. Patients must have recovered to NCI CTCAE v3.0< or equal Grade 1 from all acute toxicities (excluding toxicities that are not considered a safety risk by the sponsor and investigator such as alopecia or residual peripheral neuropathy resulting from prior systemic therapy) or the toxicity must be deemed irreversible by the investigator.
6.At least one week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy.
7.Patients must have adequate hematologic, renal and liver function determined within 14 days prior to enrollment, defined as:
a.Absolute neutrophil count > or equal 1.0 x 10e9 cells/L.
b.Platelets > or equal 50 x 10e9/L.
c.Hemoglobin > or equal 8 g/dL.
d.Aspartate and alanine aminotransferases (AST, ALT) < or equal 5 x ULN (upper limit of normal).
e.Total serum bilirubin < or equal 2 x ULN
f.Serum creatinine < or equal 2.0 mg/dL.
8.Negative pregnancy test within 72 hours of initial dose of CP-751,871 for females of child-bearing potential. Patients must be surgically sterile or postmenopausal females, or must agree to use double barrier contraception during the period of therapy and for 5 months following the last dose of the study drug. Double barrier contraception is defined as male condom plus spermicide in combination with a female condom, diaphragm, or cervical cap; or male condom plus spermicide in combination with an intrauterine device. Within these limits, the specific form of contraception employed is left to the discretion of the patient or the principal investigator.
9.Evidence of a personally signed and dated informed consent indicating that the patient (or a legally acceptable representative) has been informed of all the pertinent aspects of the study.
10.Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Concomitant treatment with other anti-cancer therapy.
2.Prior anti IGF-IR based investigational therapy. Other investigational therapies (targeted or vaccine), unless otherwise agreed by investigators and sponsor, will require 4 weeks wash-out period or 5 half-lives of the agent, which ever is sooner, before enrollment.
3.Symptomatic brain metastases. Brain metastases stable for <2 weeks before dosing or requiring concurrent steroid therapy or with clinical symptoms. Clinical symptoms suggestive of new brain metastasis within 2 weeks of enrollment. If such evidence exists, new brain metastasis must be ruled out by a CT scan or MRI. Patients that develop brain metastasis during the study will not need to have their treatment interrupted to receive a course of cranial radiation.
4.Major surgery within 4 weeks prior to study enrollment or not fully recovered from side effects of previous procedures.
5.Previous or current malignancies at sites other than basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix that has been adequately treated with no evidence of recurrent disease for 12 months.
6.Significant active cardiac disease including: uncontrolled high blood pressure (ie, systolic blood pressure >180 mm Hg, diastolic blood pressure >95 mm Hg), unstable angina, deep venous thrombosis, pulmonary embolism, cerebro vascular attack, valvular disease, congestive heart failure, myocardial infarction (within the previous 6 months), or serious cardiac arrhythmias.
7.Patients who are receiving chronic high-dose systemic immunosuppressive steroid therapy (> or equal 100 mg prednisone per day or >40 mg dexamethasone per day). Use of high-dose corticosteroids within 2 weeks prior to enrollment.
8.Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
9.Pregnancy or breast feeding.
10.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method