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A Phase II Study of CP-751,871 in Patients With Recurrent and/or Metastatic Squamous Head and Neck Carcinoma

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

A Phase II Study of CP-751,871 in Patients With Recurrent and/or Metastatic Squamous Head and Neck Carcinoma

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 discontinuation from the study for any other reason.

Since, head and neck tumors are easily accessible for iterative biopsy, this study will
offer the opportunity to get tumor biopsies before and after CP-751,871. Our study will
allow translational research with biopsies at crucial timing:

(i) at baseline before any treatment, (ii) during the treatment with CP-751,871 (day 1,
second cycle two hours after the injection of CP-751,871).

(iii) for patients with stable disease or partial response, a new biopsy will be performed
at the time of disease progression to try to understand the mechanisms of tumor resistance.

The baseline samples will allow an investigation of molecular profiles that reflect an
inherent inter-patient variability and which will be predictive of response. Although the
number of patients included is low, these data may contribute to understand the mechanisms
of response and non-response to CP-751,871. Understanding the mechanisms of response to
CP-751,871 will help in the rational design of further clinical trials in head and neck
cancer using CP-751,871.

The on-treatment samples will help to dynamically monitor the molecular response to

The study of involved pathways before and after administration of CP-751,871 could be
performed using IHC, DNA sequence analysis and RNA expression profiling. Plasma samples
could be also stored for further analysis.

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

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the efficacy of CP-751,871 alone in patients with head and neck cancer in term of overall response rate and stable disease (RECIST)

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Jean-Pascal Machiels, MDPhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cliniques Universitaires Saint-Luc-UCL


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

GORTEC 2008/02



Start Date:

January 2009

Completion Date:

September 2010

Related Keywords:

  • Head and Neck Cancer
  • CP-751,871
  • squamous cell carcinoma
  • recurrent or metastatic
  • after 1st line chemotherapy
  • Carcinoma
  • Head and Neck Neoplasms
  • Carcinoma, Squamous Cell