Study of Adding Cetuximab to Chemotherapy for the Treatment of Advanced and/or Recurrent Cervical Cancer

Cervical Cancer Clinical Trial

— MITO CERV 2  

Official title:

Randomized Phase II Study of Carboplatin and Paclitaxel +/- Cetuximab, in Advanced and/or Recurrent Cervical Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00997009
• Other study ID #: MITO CERV 2
• Secondary ID: 2009-010099-74
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 2009
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 blocks the epidermal growth factor receptor (anti-EFGR), and has shown significant activity in other cancers (colon, head and neck) where expression of EGFR is high. Cervical cancer cells express EGFR in a very high proportion of cases, especially in recurrent or resistant disease. This study evaluates the activity of the addition of cetuximab to full doses of carboplatin and paclitaxel.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Italy	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	Milano
Italy	A.O. Unversitaria Policlinico	Modena
Italy	A.O. Universitaria Federico II	Napoli
Italy	Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico	Napoli
Italy	Seconda Università di Napoli	Napoli
Italy	Istituto Oncologico Veneto	Padova
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

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	event free survival		after 3 and 6 cycles of treatment (each cycle is 21 days), and every 3 months thereafter up to 18 months
Secondary	adverse events	according CTCAE criteria	after each treatment cycle (each cycle is 21 days) up to 30days
Secondary	overall survival		18 months
Secondary	skin toxicity and correlation with cetuximab activity		after 3 and 6 cycles of therapy (each cycle is 21 days), and every 3 months thereafter up to 18 months
Secondary	EGFR/KRAS expression and correlation with cetuximab activity		at 18 months