Study of Adding Cetuximab to Chemotherapy for the Treatment of Advanced and/or Recurrent Cervical Cancer
NCT ID: NCT00997009
Last Updated: 2023-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
108 participants
INTERVENTIONAL
2009-10-31
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cetuximab and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
NCT00101192
Randomised Phase II, Cetuximab in Combination With 5FU and Cisplatin or Carboplatin Versus Cetuximab in Combination With Paclitaxel and Carboplatin for Treatment of Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT01830556
Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
NCT00999700
Cetuximab, Cisplatin, and Radiotherapy in Women With Locally Advanced Cervical Carcinoma
NCT00292955
Cetuximab, Chemotherapy, and Radiation Therapy for Operable Stage III or IV Head and Neck Cancer
NCT00089297
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A
chemotherapy plus cetuximab
paclitaxel
175 mg/m2 IV day 1, every 21 days
carboplatin
AUC 5 IV day 1 every 21 days
cetuximab
400 mg/m2 IV, one week before starting carboplatin and paclitaxel; then 250 mg/m2 IV day 1, weekly
Arm B
chemotherapy
paclitaxel
175 mg/m2 IV day 1, every 21 days
carboplatin
AUC 5 IV day 1 every 21 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
paclitaxel
175 mg/m2 IV day 1, every 21 days
carboplatin
AUC 5 IV day 1 every 21 days
cetuximab
400 mg/m2 IV, one week before starting carboplatin and paclitaxel; then 250 mg/m2 IV day 1, weekly
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute, Naples
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sandro Pignata, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Francesco Perrone, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Alessandro Morabito, M.D.,
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Ciro Gallo, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Campania Luigi Vanvitelli
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ospedale Senatore Antonio Perrino
Brindisi, , Italy
Ospedale Oncologico A. Businco
Cagliari, , Italy
Universita Cattolica del Sacro Cuore
Campobasso, , Italy
Istituto Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
Istituto Nazionale Tumori
Milan, , Italy
A.O. Unversitaria Policlinico
Modena, , Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
Napoli, , Italy
A.O. Universitaria Federico II
Napoli, , Italy
Seconda Università di Napoli
Napoli, , Italy
Istituto Oncologico Veneto
Padua, , Italy
Ospedale Silvestrini
Perugia, , Italy
Istituto Regina Elena
Roma, , Italy
Universita Cattolica del Sacro Cuore
Roma, , Italy
Ospedale S. Chiara
Trento, , Italy
A.O. di Udine S. Maria della Misericordia
Udine, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-010099-74
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MITO CERV 2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.