NCT00997009

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_2

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
15.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 14, 2023

Status Verified

March 1, 2023

Enrollment Period

15.2 years

First QC Date

October 15, 2009

Last Update Submit

November 9, 2023

Conditions

Cervical Cancer

Keywords

EGFRchemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • adverse events

    after each treatment cycle (each cycle is 21 days) up to 30days

  • overall survival

    18 months

  • 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

  • EGFR/KRAS expression and correlation with cetuximab activity

    at 18 months

Study Arms (2)

Arm A

EXPERIMENTAL

chemotherapy plus cetuximab

Drug: paclitaxelDrug: carboplatinDrug: cetuximab

Arm B

ACTIVE COMPARATOR

chemotherapy

Drug: paclitaxelDrug: carboplatin

Interventions

paclitaxelDRUG

175 mg/m2 IV day 1, every 21 days

Arm AArm B
carboplatinDRUG

AUC 5 IV day 1 every 21 days

Arm AArm B
cetuximabDRUG

400 mg/m2 IV, one week before starting carboplatin and paclitaxel; then 250 mg/m2 IV day 1, weekly

Arm A

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Ospedale Senatore Antonio Perrino

Brindisi, Italy

Location

Ospedale Oncologico A. Businco

Cagliari, Italy

Location

Universita Cattolica del Sacro Cuore

Campobasso, Italy

Location

Istituto Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Italy

Location

Istituto Nazionale Tumori

Milan, Italy

Location

A.O. Unversitaria Policlinico

Modena, Italy

Location

Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico

Napoli, 80131, Italy

Location

A.O. Universitaria Federico II

Napoli, Italy

Location

Seconda Università di Napoli

Napoli, Italy

Location

Istituto Oncologico Veneto

Padua, Italy

Location

Ospedale Silvestrini

Perugia, Italy

Location

Istituto Regina Elena

Roma, Italy

Location

Universita Cattolica del Sacro Cuore

Roma, Italy

Location

Ospedale S. Chiara

Trento, Italy

Location

A.O. di Udine S. Maria della Misericordia

Udine, Italy

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

PaclitaxelCarboplatinCetuximab

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • 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.

    University of Campania Luigi Vanvitelli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 16, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 14, 2023

Record last verified: 2023-03

Locations

IT(15)