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Phase 2 N=31 Treatment

Sunitinib Malate in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Recurrent Fallopian Tube Cancer · Recurrent Ovarian Epithelial Cancer · Recurrent Primary Peritoneal Cavity Cancer · Stage IIIA Fallopian Tube Cancer · Stage IIIA Ovarian Epithelial Cancer

Enrolled (actual)
31
Serious AEs
50.0%
Results posted
Jan 2015
Primary outcome: Primary: Objective Response (Partial Response or Complete Response) as Per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria — 3.6 percentage of evalubale patients

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
sunitinib malate (Drug); laboratory biomarker analysis (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
National Cancer Institute (NCI)
Primary completion
Jan 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Objective Response (Partial Response or Complete Response) as Per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
3.6

Summary

This phase II trial studies the side effects and how well sunitinib malate works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer. Sunitinib malate may inhibit the ability of cancers to grow blood vessels, something they need to grow. It may also shrink tumors.

Eligibility Criteria

Inclusion Criteria

  • Patients must have histologically confirmed epithelial ovarian, primary fallopian or primary peritoneal cancer
  • Patients must have advanced and/or metastatic disease, incurable by standard therapies
  • Patients must have received one or two prior chemotherapy regimens (one must have been platinum containing) and may be either platinum sensitive or platinum resistant
  • Nota bene (NB): For the purposes of this trial, switching from one platinum compound to another for reasons of disease progression or failure to respond will be considered a second regimen; as well, the same regimen given as first and second-line therapy is also considered two regimens
  • 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; N.B.: Most Canadian hospitals have spiral CT scanning equipment
  • Non-spiral CT scan >= 20 mm; N.B.: Most Canadian hospitals have spiral CT scanning equipment
  • All radiology studies must be performed within 21 days prior to registration (within 28 days if negative)
  • Patients with CA125 as only evidence of disease are not eligible
  • Patients must have a life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Hormonal therapy: Patients may have had up to one prior hormonal treatment for metastatic disease; patients must be at least 28 days since last dose of hormonal therapy
  • Chemotherapy: Patients must have had a minimum of one and up to two prior chemotherapy regimens, one of which must have contained a platinum agent; patients must be at least 28 days since last chemotherapy treatment and must have recovered from toxic effects
  • Radiation: Patients may have had prior radiation therapy; a minimum of 28 days must have elapsed between the end of radiotherapy and registration onto the study; radiation must have involved = 1.5 x 10^9/L
  • Platelets >= 100 x 10^9/L
  • Bilirubin = = 60 ml/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; 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, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no e
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00388037). 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.

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