A Study of CP-751,871 in Patients With Recurrent Squamous Head and Neck Carcinoma

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

1. Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation.

2. Recurrence must be confirmed by anatomopathology (cytology or biopsy)

3. At least one measurable lesion by MRI or CT-scan.

4. Failed or relapsing after first line chemotherapy including a platinum* or a taxane-based chemotherapy regimen

5. Patients ineligible for chemotherapy could be included in first line

6. ECOG performance status 0 -2, in stable medical condition

7. Patients must have an expected survival of at least 3 months.

8. Paraffin-embedded tumor tissue available for immunohistochemistry

9. Patients must be over 18 years old and must be able to give written informed consent

10. 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).

11. 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

12. Acceptance of giving 20 ml of blood for eventual research at baseline

13. Acceptance of giving two plasma samples (3ml) at baseline and after 3 weeks of treatment

14. Signed informed consent prior to beginning protocol specific procedure

15. 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 Criteria:

1. Non-squamous head and neck cancer

2. Nasopharynx cancer

3. Brain metastases

4. 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)

5. Surgery or irradiation or investigational drugs within 4 weeks before study inclusion

6. 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

7. 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).

8. Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …)

9. Previous malignancy, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

10. Other concomitant anticancer therapies.

11. Previous treatment with anti-EGFR therapy is not an exclusion criteria.

12. Prior anti-IGF-1R therapy

13. Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.