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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00997009
First received: October 15, 2009
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention Phase
Cervical Cancer
Drug: paclitaxel
Drug: carboplatin
Drug: cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Carboplatin and Paclitaxel +/- Cetuximab, in Advanced and/or Recurrent Cervical Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • event free survival [ Time Frame: after 3 and 6 cycles of treatment, and every 3 months thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicity [ Time Frame: after each treatment cycle ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • skin toxicity and correlation with cetuximab activity [ Time Frame: after 3 and 6 cycles of therapy, and every 3 months thereafter ] [ Designated as safety issue: No ]
  • EGFR/KRAS expression and correlation with cetuximab activity [ Time Frame: at 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: October 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
chemotherapy plus cetuximab
Drug: paclitaxel
175 mg/m2 IV day 1, every 21 days
Drug: carboplatin
AUC 5 IV day 1 every 21 days
Drug: cetuximab
400 mg/m2 IV, one week before starting carboplatin and paclitaxel; then 250 mg/m2 IV day 1, weekly
Active Comparator: Arm B
chemotherapy
Drug: paclitaxel
175 mg/m2 IV day 1, every 21 days
Drug: carboplatin
AUC 5 IV day 1 every 21 days

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997009

Locations
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
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
Napoli, Italy, 80131
Seconda Università di Napoli
Napoli, Italy
A.O. Universitaria Federico II
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, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
Principal Investigator: Sandro Pignata, M.D., Ph.D. National Cancer Institute, Naples
Principal Investigator: Francesco Perrone, M.D., Ph.D. National Cancer Institute, Naples
Principal Investigator: Alessandro Morabito, M.D., National Cancer Institute, Naples
Principal Investigator: Ciro Gallo, M.D., Ph.D. Second University of Naples
  More Information

No publications provided

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00997009     History of Changes
Other Study ID Numbers: MITO CERV 2, 2009-010099-74
Study First Received: October 15, 2009
Last Updated: July 29, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
EGFR
chemotherapy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cetuximab
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014