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

NCT00872404 | Terminated Phase 2

• 1 other identifier: GORTEC 2008/02
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Cancer

Keywords

CP-751,871; squamous cell carcinoma; recurrent or metastatic; after 1st line chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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)

  8 weeks

Secondary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

CP-751,871 DRUG

20mg/kg/3 weeks

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)
• 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.
• Prior anti-IGF-1R therapy
• Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (2)

Cliniques universitaires Mont-Godinne

Yvoir, Namur, 5530, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell; Recurrence; Neoplasm Metastasis

Interventions

figitumumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Study Officials

• Jean-Pascal Machiels, MDPhD

  Cliniques Universitaires Saint-Luc-UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

BE (2)