Phase 2
N=31
Brivanib Alaninate in Treating Patients With Persistent or Recurrent Cervical Cancer
Cervical Adenocarcinoma · Cervical Adenosquamous Carcinoma · Cervical Squamous Cell Carcinoma, Not Otherwise Specified · Persistent Disease · Recurrent Cervical Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01267253 ↗Enrolled (actual)
31
Serious AEs
50.0%
Results posted
Jan 2017
Primary outcome: Primary: Objective Tumor Response — 0.071 proportion
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Brivanib Alaninate (Drug); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Gynecologic Oncology Group
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Tumor Response |
0.071 | — |
| PRIMARY PFS for at Least 6 Months Without Non-protocol Therapy From Study Entry. |
0.179 | — |
| PRIMARY Adverse Events (Grade 3 or Higher) During Treatment Period |
0; 0; 0; 4; 4; 1 | — |
| SECONDARY Progression-free Survival |
3.2 | — |
| SECONDARY Overall Survival |
7.9 | — |
Summary
This phase II trial studies how well brivanib alaninate works in treating patients with cervical cancer that has come back. Brivanib alaninate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
Eligibility Criteria
Inclusion Criteria
- Patients must have persistent or recurrent squamous cell carcinoma, adenosquamous carcinoma, adenocarcinoma, or non-squamous cell carcinoma of the cervix with documented disease progression (disease not amenable to curative therapy); histologic confirmation of the original primary tumor is required via the pathology report
- All patients must have measurable disease, defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
- Patient must have at least one ?target lesion? to be used to assess response on this protocol as defined by RECIST 1.1
- Tumors within a previously irradiated field will be designated as ?non-target? lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists
- In general, this would refer to any active GOG phase III protocol or rare tumor protocol for the same patient population
- Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2
- Patients who have received two prior regimens must have a GOG performance status of 0 or 1
- Recovery from effects of recent surgery, radiotherapy, or chemotherapy
- Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
- Any other prior therapy directed at the malignant tumor, including chemotherapy and immunologic agents, must be discontinued at least three weeks prior to registration
- Any prior radiation therapy must be completed at least 4 weeks prior to registration
- At least 4 weeks must have elapsed from the time of any major surgical procedure
- Patients must have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent carcinoma of the cervix; chemotherapy administered concurrent with primary radiation (e.g.; weekly cisplatin) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease; adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease (e.g.; paclitaxel and carboplatin for up to 4 cycles)
- Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease
- Patients must have NOT received any non-cytotoxic (biologic or targeted) agents as part of their primary treatment or for management of recurrent or persistent disease
- Non-cytotoxic (biologic or targeted) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
- Platelets greater than or equal to 100,000/mcl
- Hemoglobin >= 9 g/dl
- Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
- Urinalysis needs to be assessed at baseline and proteinuria must be less than or equal to 2+ by dipstick
- If the urine dipstick is > 2+, a 24-hour protein level can be done, as clinically indicated by the investigator
- The 24-hour protein level must be less than or equal to 3.5 g/24 hours
- Bilirubin less than or equal to 1.5 x ULN
- Aspa
Data sourced from ClinicalTrials.gov (NCT01267253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.