JCOG1311: Randomized Phase II/III Trial of Conventional Paclitaxel and Carboplatin with/without Bevacizumab versus Dose-dense Paclitaxel and Carboplatin with/without Bevacizumab in Stage IVB, Recurrent, or Persistent Cervical Carcinoma
- Conditions
- Metastatic or Recurrent Cervical Carcinoma, not amenable to curative surgery or radiotherapy
- Registration Number
- JPRN-jRCTs031180007
- Lead Sponsor
- Ishikawa Mitsuya
- Brief Summary
Dose-dense, weekly paclitaxel plus carboplatin is not promising for metastatic or recurrent cervical carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 122
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, progression, or persistent cervical cancer after curative first line treatments
3. the second relapse, progression, 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 including the first treatment and the treatment for progression or relapse after the first treatment
3. prior adjuvant chemotherapy for initial treatment including two or more regimens
4. prior systemic chemotherapy for metastatic or relapse regions
5. progression during 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 radiation
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
1. <= Grade 1, Peripheral motor neuropathy
2. <= Grade 1, Peripheral sensory neuropathy
11) Sufficient organ functions with the latest laboratory examination within 14 days before registration
12) Normal ECG within 28 days before registration
13) Written informed consent
1) Simultaneous or metachronous 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 difficult to participate in this clinical study.
6) Continuous systemic steroid treatment or other immunosuppressive agent
7) Uncontrolled diabetes mellitus or routine administration of insulin
8) Uncontrolled hypertension
9) Unstable angina or prior myocardial infarction within 6 months
10) Metastasis to central nerve system with a symptom
11) Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema diagnosed with chest CT
12) HBs antigen positive, HCV antibody positive, HIV antibody positive
13) hypersensitivity to polyoxyethylated castor oil
14) hypersensitivity to alcohol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 (in cases of more than seven courses) (day 1 denotes the initial date of each course))<br>Phase III: Overall survival
- Secondary Outcome Measures
Name Time Method Phase II: Adverse events, Serious adverse events<br>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