Status:
UNKNOWN
Study of Adding Cetuximab to Chemotherapy for the Treatment of Advanced and/or Recurrent Cervical Cancer
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study aims to assess the activity of a combination of cetuximab (weekly) with carboplatin + paclitaxel (every three weeks) comparing it to chemotherapy alone in terms of event-free survival (EFS)...
Detailed Description
The poor long-term results in the standard treatment of chemotherapy for cervical cancer make research into new, more beneficial treatment strategies necessary. Cetuximab is a new type of drug that bl...
Eligibility Criteria
Inclusion
- Advanced and/or metastatic cervical cancer patients untreated or having failed only one previous chemotherapy (with at least 6 months of progression free interval, with or without concomitant or sequential radiotherapy).
- At baseline, presence of at least one measurable target lesion (a lesion that can be accurately measured in at least one dimension i.e. longest diameter at least 20 mm with conventional CT scan or at least 10 mm with spiral CT scan according to RECIST Criteria).
- Not amenable to surgery and/or radiotherapy.
- PS 0-1 according to ECOG.
- Age \>18.
- Life expectancy of at least 3 months.
- Adequate organ functions
- Hematopoietic: Leukocytes \> 3,000/mm3; Absolute neutrophil count \> or = 1,500/mm3; Platelets count \> or = 100,000/mm3; Hemoglobin \> or = 9 g/dL
- Hepatic: AST and ALT \< or = 3 times upper limit of normal (ULN)\*; Alkaline phosphatase \< or = 3 times ULN\*; Bilirubin \< or = 1.5 times ULN
- \*: \< or = 5 times ULN if liver metastases are present
- Renal: Creatinine clearance \> or = 45 mL/min
- No other invasive malignancy within the past 5 years except non-melanoma skin cancer.
- All radiology studies must be performed within 28 days prior to randomization.
- Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule.
- Written informed consent.
Exclusion
- Pregnant (potentially fertile patients must use contraceptive measures to avoid pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test at baseline).
- Patients should not be breast-feeding during treatment and for 2 months following the end of treatment.
- More than one previous chemotherapy line.
- Active infection requiring antibiotics.
- Symptomatic peripheral neuropathy \>grade 2 according to the CTCAE.
- Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia.
- Known hypersensitivity to the study drugs or to drugs with similar chemical structures.
- Concurrent treatment with other experimental drugs.
- Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00997009
Start Date
October 1 2009
End Date
December 1 2024
Last Update
November 14 2023
Active Locations (15)
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1
Ospedale Senatore Antonio Perrino
Brindisi, Italy
2
Ospedale Oncologico A. Businco
Cagliari, Italy
3
Universita Cattolica del Sacro Cuore
Campobasso, Italy
4
Istituto Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy