Phase 2
N=19
Sunitinib Malate in Treating Patients With Uterine Cervical Cancer That is Stage IVB, Recurrent, or Cannot Be Removed By Surgery
Cervical Adenocarcinoma · Cervical Adenosquamous Cell Carcinoma · Cervical Squamous Cell Carcinoma · Recurrent Cervical Cancer · Stage IVB Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00389974 ↗Enrolled (actual)
19
Serious AEs
73.7%
Results posted
Feb 2015
Primary outcome: Primary: Objective Response Rate (PR or CR) — 0 percentage of evalubale patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sunitinib malate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (PR or CR) |
— | — |
Summary
This phase II trial studies the side effects and how well sunitinib malate works in treating patients with cervical cancer which cannot be cured by standard therapy. Sunitinib malate may stop the growth of cervical cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically or cytologically confirmed squamous cell carcinoma or adenosquamous carcinoma of the cervix; patients with adenocarcinoma of the cervix will also be included since, although infrequent, their management in general is similar to those with squamous tumors
- Patients must have advanced (stage IVB) recurrent or persistent disease unsuitable for curative treatment by surgery and/or radiation therapy
- Presence of clinically and/or radiologically documented disease; at least one site of disease must be unidimensionally measurable as follows:
- X-ray, physical exam >= 20 mm
- Spiral computed tomography (CT) scan >= 10 mm
- Non-spiral CT scan >= 20 mm
- All radiology studies must be performed within 21 days prior to registration (within 28 days if negative)
- Patients must have a life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; performance status (PS) 2 patients are eligible if, in the opinion of the investigator, they are suitable for inclusion in the study and are likely to be compliant with the study procedures (in particular the recommendations for supportive care and dose modifications)
- Patients may have had neoadjuvant or adjuvant chemotherapy
- Patients may have had concurrent chemoradiation; this is not considered neoadjuvant or adjuvant treatment
- Patients may have had no more than one prior chemotherapy regimen for recurrent metastatic disease; patients must be at least 28 days since last chemotherapy treatment and must have recovered from toxic effects
- Patients may have had prior radiation therapy, including external beam and/or intracavity radiation; a minimum of 28 days must have elapsed between the end of radiotherapy and registration onto the study; patients must have recovered from any acute toxic effects from radiation prior to registration; radiation must have involved = 1.5 x 10^9/L
- Platelets >= 100 x 10^9/L
- Bilirubin = = 60ml/min if creatinine is > ULN; creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft Formula
- Patient consent must be obtained according to local institutional and/or University Human Experimentation Committee requirements; it will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) study coordinator that such clearance has been obtained, before the trial can commence in that center; because of differing requirements, a standard consent form for the trial will not be provided; a copy of the initial full board Research Ethics Board (REB) approval and approved consent form must be sent to the central office; the patient must sign the consent form prior to randomization or registration; please note that the consent form for this study must contain a statement which gives permission for the NCIC CTG and monitoring agencies to review patient records
- Patients must be accessible for treatment, response assessment and follow-up; patients registered on this trial must be treated and followed at the participating center; this implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial; investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
- In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient registration; exceptions may be made however, regarding the washout period timing for prohibited medications
Exclusion Criteria
- History of other malignancies, except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for >= 5 years
- Patients with known brain metastases; (a head C
Data sourced from ClinicalTrials.gov (NCT00389974). 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.