Study of Adding Cetuximab to Chemotherapy for the Treatment of Advanced and/or Recurrent Cervical Cancer (MITO CERV 2)
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ClinicalTrials.gov Identifier: NCT00997009 |
Recruitment Status :
Active, not recruiting
First Posted : October 16, 2009
Last Update Posted : November 14, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Cancer | Drug: paclitaxel Drug: carboplatin Drug: cetuximab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 108 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Phase II Study of Carboplatin and Paclitaxel +/- Cetuximab, in Advanced and/or Recurrent Cervical Cancer |
Study Start Date : | October 2009 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
---|---|
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 |
- event free survival [ Time Frame: after 3 and 6 cycles of treatment (each cycle is 21 days), and every 3 months thereafter up to 18 months ]
- adverse events [ Time Frame: after each treatment cycle (each cycle is 21 days) up to 30days ]according CTCAE criteria
- overall survival [ Time Frame: 18 months ]
- skin toxicity and correlation with cetuximab activity [ Time Frame: 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 [ Time Frame: at 18 months ]
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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.
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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
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997009
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 | |
A.O. Universitaria Federico II | |
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, Italy |
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. | University of Campania "Luigi Vanvitelli" |
Responsible Party: | National Cancer Institute, Naples |
ClinicalTrials.gov Identifier: | NCT00997009 |
Other Study ID Numbers: |
MITO CERV 2 2009-010099-74 ( EudraCT Number ) |
First Posted: | October 16, 2009 Key Record Dates |
Last Update Posted: | November 14, 2023 |
Last Verified: | March 2023 |
EGFR chemotherapy |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Genital Diseases Paclitaxel Carboplatin Cetuximab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological |