Metastatic or Recurrent Cervical Carcinoma, not amenable to curative surgery or radiotherapy
Conditions
Interventions
A: Chemotherapy: Paclitaxel / Carboplatin with/without Bevacizumab (Paclitaxel 175 mg/m2 day1, Carboplatin AUC5 day1, Bevacizumab 15 mg/kg day1, repeated every 3 weeks for 6 cycles. Protocol treatment
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Uterine cervical cancer histologically proven by biopsy to the primary tumor 2) Squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix 3) One of the followings: 1. primary stage IVb cervical cancer 2. the first relapse or persistent cervical cancer after curative first line treatments 3. the second relapse or persistent cervical cancer after curative second line treatments for the first relapse 4) One of the followings: 1. There is at least one metastatic lesion outside the pelvic cavity except paraaortic LN and/or inguinal LN 2. There is no metastatic lesion outside the pelvic cavity except paraaortic LN and/or inguinal LN and either of paraaortic or inguinal LN has been irradiated 3. All lesions are localized inside the pelvic cavity, and some of them have been irradiated 5) No prior treatment of the followings was done, 1. prior surgical therapy for relapse inside the pelvic cavity with resection of bladder or intestinal tract 2. prior chemoradiation twice or more 3. prior adjuvant chemotherapy for initial treatment including two or more regimens 4. prior chemotherapy for metastatic or relapse regions 5. progression during prior neoadjuvant chemotherapy of taxane-platinum regimen 6. relapse or progression within 24 weeks after adjuvant chemotherapy of taxane-platinum regimen 6) Certain interval from the last administration of previous treatments as the followings 1. 42 days or more after prior chemoradiation 2. 21 days or more after prior radiatin 3. 28 days or more after prior surgical treatment 4. 14 days or more after prior adjuvant chemoterapy 7) Age: 20 to 75 years 8) PS: 0-2 9) No bilateral hydronephrosis 10) Peripheral motor neuropathy <= Grade 1, Peripheral sensory neuropathy <= Grade 1 11) Sufficient organ functions with the latest laboratory examination within 14 days 12) Normal ECG 13) Written informed consent
Exclusion criteria
Exclusion criteria: (1) Simultaneous or metachronous (within 5 years) double cancers. (2) Active systemic infections to be treated. (3) Body temperature of 38 or more degrees Celsius (4) Women during pregnancy, possible pregnancy, or breast-feeding (5) Psychiatric disease (6) Continuous systemic steroid treatment (7) Uncontrolled diabetes mellitus or routine administration of insulin (8) Uncontrolled hypertension (9) Unstable angina or prior myocardial infarction with in 6 months (10) Metastasis to central nerve system with a symptom (11) Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema (12) HBs antigen positive, HCV antibody positive, HIV antibody positive (13) hypersensitivity to polyoxyethylated castor oil (14) hypersensitivity to alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II: Response Rate (Assessed in the following timing: i) day 15-21 in the 3rd course, ii) day 15-21 in the 6th course, iii) day 22-56 in the last course (day 1 denotes the initial date of each course)), Phase III: Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: Adverse Events, Serious Adverse Events Phase III: Progression-free Survival, Response Rate, Adverse Events, Serious Adverse Events, Proportion of periods of non-hospitalization to those of the planned treatment during the first 6 courses | — |
Countries
Japan
Contacts
Public ContactMitsuya Ishikawa
JCOG1311 Coordinating Office Division of Gynecology, National Cancer Center Hospital
Outcome results
None listed