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SCCA Gynecologic Cancer Clinical Trials

Cediranib Maleate in Recurrent or Persistent Endometrial Cancer (GOG 229-J)
A Phase II Evaluation of Cediranib (Recentin; AZD2171, IND# 72740, NSC# 732208) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Status Conditions Phase Study ID
Closed Endometrial Cancer II GOG 229-J
NCT01132820
Summary

The primary objectives of this study are to determine the response at 6 months of patients with persistent or recurrent endometrial carcinoma treated with cediranib maleate.


Investigator
Benjamin Greer, MD
Location    
Multicare Health System, Tacoma WA 253-403-5265  
Olympic Medical Center, Sequim WA 360-683-9895  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Group Health 206-225-7893  
Eligibility Criteria (must meet the following to participate in this study)
  • Histologically confirmed primary endometrial carcinoma including any of the following epithelial cell types:

    • Endometrioid adenocarcinoma
    • Serous adenocarcinoma
    • Undifferentiated carcinoma
    • Clear cell adenocarcinoma
    • Mixed epithelial carcinoma
    • Adenocarcinoma not otherwise specified
    • Mucinous adenocarcinoma
    • Squamous cell carcinoma
    • Transitional cell carcinoma
  • Recurrent or persistent disease

    • Refractory to curative therapy or established treatments
  • Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded)

    • Lesion must be ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical exam OR ≥ 20 mm by chest x-ray
    • Lymph nodes must be > 15 mm in short axis by CT scan or MRI
  • Patient must have ≥ 1 "target lesion" to assess response as defined by RECIST v. 1.1

    • Tumors within a previous irradiated field are designated as non-target lesions unless progression is documented OR a biopsy is obtained to confirm persistence of disease ≥ 90 days after completion of radiotherapy
  • Patient must not be eligible for a higher priority GOG protocol, if one exists
  • Must have had 1 prior chemotherapeutic regimen for management of endometrial cancer that may include 1 of the following:

    • Chemotherapy
    • Chemotherapy and radiotherapy

      • Chemotherapy in conjunction with primary radiotherapy as a radio-sensitizer will be counted as a systemic chemotherapy regimen
    • Consolidation and/or maintenance therapy
  • No CNS disease, including primary brain tumor or brain metastases

PATIENT CHARACTERISTICS:

  • GOG performance status (PS) 0-2 (for patients who received 1 prior therapeutic regimen) OR GOG PS 0-1 (for patients who received 2 prior regimens)
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 1.5 times upper limit of normal (ULN) OR Creatinine clearance ≥ 60 mL/min
  • Urine protein:creatinine (UPC) ratio < 1.0 g
  • Bilirubin ≤ 1.5 times ULN
  • AST ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • INR ≤ 1.5 times ULN (between 2 and 3 for patients on stable dose of therapeutic warfarin)
  • PTT ≤ 1.5 times ULN
  • Amylase and lipase normal
  • Thyroid stimulation hormone (TSH) and free thyroxine (Free T4) normal
  • Peripheral neuropathy (sensory and motor) ≤ grade 1
  • Negative pregnancy test
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
Exclusions (conditions that would prevent participation in this study)
  • No active infection requiring antibiotics

    • Uncomplicated urinary tract infection allowed
  • No invasive malignancies within the past 3 years except nonmelanoma skin cancer or curatively treated localized cancer of the breast, head and neck, or skin
  • No serious non-healing wound, ulcer, or bone fracture, including the following:

    • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No active bleeding or pathological conditions that carry high-risk of bleeding, including the following:

    • Known bleeding disorder
    • Coagulopathy disorder
    • Tumor involving major vessels
  • No uncontrolled seizures with standard medical therapy
  • No clinically significant cardiovascular disease including, but not limited to, any of the following:

    • Uncontrolled hypertension (defined as systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg despite optimized antihypertensive therapy)
    • Myocardial infarction or unstable angina within the past 6 months
    • NYHA grade II-IV congestive heart failure or serious cardiac arrhythmia requiring medication

      • Patients who received prior anthracycline treatment, including doxorubicin hydrochloride and/or liposomal doxorubicin, and have an ejection fraction < normal are not eligible for this study
    • Peripheral vascular disease ≥ grade 2 as assessed by NCI CTCAE
    • History of cerebrovascular accident (e.g., CVA, stroke), transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
    • Mean QTc > 500 msec or history of familial long QT syndrome
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • Recovered from recent surgery, radiotherapy, or chemotherapy
  • At least 1 week since prior hormonal therapy directed at the malignant tumor
  • At least 3 weeks since any other prior anticancer therapy
  • One prior cytotoxic regimen for management of recurrent or persistent disease allowed

    • Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
  • No prior non-cytotoxic chemotherapy for management of recurrent or persistent disease

    • Prior hormonal therapy allowed
  • No prior cediranib maleate or other VEGF pathway-targeted therapy
  • No prior cancer treatment that contraindicates this protocol therapy
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis within the past 3 years other than treatment for endometrial cancer

    • Prior radiotherapy for localized cancer of the breast, head and neck, or skin allowed provided it was completed > 3 years and patient remains free of recurrent or metastatic disease
  • No prior chemotherapy for any abdominal or pelvic tumor other than for endometrial cancer within the past 5 years

    • Prior adjuvant chemotherapy for localized breast cancer allowed provided it was completed > 3 years and patient remains free of recurrent or metastatic disease
  • No major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days
  • No anticipation of major surgical procedure during the course of the study
  • No minor surgical procedures, fine needle aspirates, or core biopsies within the past 7 days
  • No concurrent amifostine or other protective reagents
Last Updated
September 12, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.