A Phase II Study of CP-751,871 in Patients With Recurrent and/or Metastatic Squamous Head and Neck Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- CP-751,871
- Conditions
- Head and Neck Cancer
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- 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)
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
1
CP-751,871 will be administered as an open-label intravenous solution. Patients will remain under clinical observation for one hour post-infusion
Intervention: CP-751,871
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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(8 weeks)