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

This study has been terminated.
(lack of efficacy)
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00872404
First received: March 30, 2009
Last updated: March 2, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: CP-751,871
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of CP-751,871 in Patients With Recurrent and/or Metastatic Squamous Head and Neck Carcinoma

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • 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) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To Determine the safety profile of CP-751,871 alone in patients with head and neck cancer. To Determine the efficacy of CP-751,871 alone in patients with head and neck cancer: progression-free survival and survival [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 37
Study Start Date: January 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CP-751,871 will be administered as an open-label intravenous solution. Patients will remain under clinical observation for one hour post-infusion
Drug: CP-751,871
20mg/kg/3 weeks

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 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 CP-751,871.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872404

Locations
Belgium
Cliniques universitaires Mont-Godinne
Yvoir, Namur, Belgium, 5530
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Jean-Pascal Machiels, MDPhD Cliniques Universitaires Saint-Luc-UCL
  More Information

No publications provided

Responsible Party: Professor J-P Machiels, Cliniques Universitaires St-Luc
ClinicalTrials.gov Identifier: NCT00872404     History of Changes
Other Study ID Numbers: GORTEC 2008/02
Study First Received: March 30, 2009
Last Updated: March 2, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
CP-751,871
squamous cell carcinoma
recurrent or metastatic
after 1st line chemotherapy

Additional relevant MeSH terms:
Carcinoma
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on September 18, 2014