Status:
TERMINATED
A Study of CP-751,871 in Patients With Recurrent Squamous Head and Neck Carcinoma
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label phase II, multicenter study. Eligible patients will receive CP-751,871 in monotherapy (20 mg/kg IV infusion on Day 1 of 3-week cycles). Tumor check-up will be performed every 6-8...
Detailed Description
CP-751,871 will be administered as an open-label intravenous solution. All patients will be treated every 3 weeks until disease progression(by RECIST criteria) or unacceptable toxicity death or discon...
Eligibility Criteria
Inclusion
- Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation.
- Recurrence must be confirmed by anatomopathology (cytology or biopsy)
- At least one measurable lesion by MRI or CT-scan.
- Failed or relapsing after first line chemotherapy including a platinum\* or a taxane-based chemotherapy regimen
- Patients ineligible for chemotherapy could be included in first line
- ECOG performance status 0 -2, in stable medical condition
- Patients must have an expected survival of at least 3 months.
- Paraffin-embedded tumor tissue available for immunohistochemistry
- Patients must be over 18 years old and must be able to give written informed consent
- Women of child-bearing age or sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine within the 7 days prior to enrollment).
- Patients must have adequate organ function (Hemoglobin ≥ 8 g/100 ml, Neutrophils ≥ 1,000/mm3, Platelets ≥ 75,000/mm3, total bilirubin \<1.5 times the upper limit of normal (ULN) for age (except for Gilbert's syndrome patients), serum alanine aminotransferase (ALT) \<2.5 ´ ULN for age, aspartate aminotransferase (AST) \<2.5 ´ ULN for age , serum creatinine £1.5 x ULN for age
- Acceptance of giving 20 ml of blood for eventual research at baseline
- Acceptance of giving two plasma samples (3ml) at baseline and after 3 weeks of treatment
- Signed informed consent prior to beginning protocol specific procedure
- Sexually active patients must use effective contraception during the period of therapy and up to 150 days after the last dose of CP-751,871. Acceptable contraception includes, but is not limited to: oral hormone therapy, partner vasectomy, or double barrier contraception (which is defined as a male condom plus spermicide in combination with either a female condom, or diaphragm, or cervical cap or intrauterine device).
Exclusion
- Non-squamous head and neck cancer
- Nasopharynx cancer
- Brain metastases
- More than two lines of chemotherapy for palliative treatment (except if chemotherapy was given as a part of a multimodal treatment given with a curative intent)
- Surgery or irradiation or investigational drugs within 4 weeks before study inclusion
- Significant active cardiac disease including: uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias
- Subjects who are receiving chronic high dose immunosuppressive steroid therapy within 2 weeks prior to enrollment (³100 mg prednisone per day or \>40 mg dexamethasone per day).
- Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …)
- Previous malignancy, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- Other concomitant anticancer therapies.
- Previous treatment with anti-EGFR therapy is not an exclusion criteria.
- Prior anti-IGF-1R therapy
- Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00872404
Start Date
January 1 2009
End Date
September 1 2010
Last Update
April 20 2016
Active Locations (2)
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1
Cliniques universitaires Mont-Godinne
Yvoir, Namur, Belgium, 5530
2
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200