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Study of Adding Cetuximab to Chemotherapy for the Treatment of Advanced and/or Recurrent Cervical Cancer (MITO CERV 2)

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
paclitaxel
carboplatin
cetuximab
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring EGFR, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ospedale Senatore Antonio Perrino
  • Ospedale Oncologico A. Businco
  • Universita Cattolica del Sacro Cuore
  • Istituto Romagnolo per lo Studio e la Cura dei Tumori
  • Istituto Nazionale Tumori
  • A.O. Unversitaria Policlinico
  • Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
  • A.O. Universitaria Federico II
  • Seconda Università di Napoli
  • Istituto Oncologico Veneto
  • Ospedale Silvestrini
  • Istituto Regina Elena
  • Universita Cattolica del Sacro Cuore
  • Ospedale S. Chiara
  • A.O. di Udine S. Maria della Misericordia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

chemotherapy plus cetuximab

chemotherapy

Outcomes

Primary Outcome Measures

event free survival

Secondary Outcome Measures

toxicity
overall survival
skin toxicity and correlation with cetuximab activity
EGFR/KRAS expression and correlation with cetuximab activity

Full Information

First Posted
October 15, 2009
Last Updated
March 3, 2021
Sponsor
National Cancer Institute, Naples
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1. Study Identification

Unique Protocol Identification Number
NCT00997009
Brief Title
Study of Adding Cetuximab to Chemotherapy for the Treatment of Advanced and/or Recurrent Cervical Cancer
Acronym
MITO CERV 2
Official Title
Randomized Phase II Study of Carboplatin and Paclitaxel +/- Cetuximab, in Advanced and/or Recurrent Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
EGFR, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
chemotherapy plus cetuximab
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
chemotherapy
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
175 mg/m2 IV day 1, every 21 days
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
AUC 5 IV day 1 every 21 days
Intervention Type
Drug
Intervention Name(s)
cetuximab
Intervention Description
400 mg/m2 IV, one week before starting carboplatin and paclitaxel; then 250 mg/m2 IV day 1, weekly
Primary Outcome Measure Information:
Title
event free survival
Time Frame
after 3 and 6 cycles of treatment, and every 3 months thereafter
Secondary Outcome Measure Information:
Title
toxicity
Time Frame
after each treatment cycle
Title
overall survival
Time Frame
18 months
Title
skin toxicity and correlation with cetuximab activity
Time Frame
after 3 and 6 cycles of therapy, and every 3 months thereafter
Title
EGFR/KRAS expression and correlation with cetuximab activity
Time Frame
at 18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandro Pignata, M.D., Ph.D.
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Perrone, M.D., Ph.D.
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alessandro Morabito, M.D.,
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ciro Gallo, M.D., Ph.D.
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Senatore Antonio Perrino
City
Brindisi
Country
Italy
Facility Name
Ospedale Oncologico A. Businco
City
Cagliari
Country
Italy
Facility Name
Universita Cattolica del Sacro Cuore
City
Campobasso
Country
Italy
Facility Name
Istituto Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
Country
Italy
Facility Name
Istituto Nazionale Tumori
City
Milano
Country
Italy
Facility Name
A.O. Unversitaria Policlinico
City
Modena
Country
Italy
Facility Name
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O. Universitaria Federico II
City
Napoli
Country
Italy
Facility Name
Seconda Università di Napoli
City
Napoli
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
Country
Italy
Facility Name
Ospedale Silvestrini
City
Perugia
Country
Italy
Facility Name
Istituto Regina Elena
City
Roma
Country
Italy
Facility Name
Universita Cattolica del Sacro Cuore
City
Roma
Country
Italy
Facility Name
Ospedale S. Chiara
City
Trento
Country
Italy
Facility Name
A.O. di Udine S. Maria della Misericordia
City
Udine
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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