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

Phase 2
18 Years
Open (Enrolling)
Cervical Cancer

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Trial Information

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

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.

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

- 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

- Concurrent treatment with other experimental drugs.

- Participation in another clinical trial with any investigational drug within 30 days
prior to study screening.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

event free survival

Outcome Time Frame:

after 3 and 6 cycles of treatment, and every 3 months thereafter

Safety Issue:


Principal Investigator

Sandro Pignata, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute, Naples


Italy: Ethics Committee

Study ID:




Start Date:

October 2009

Completion Date:

December 2014

Related Keywords:

  • Cervical Cancer
  • EGFR
  • chemotherapy
  • Uterine Cervical Neoplasms