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A Phase II Evaluation of Cediranib (Recentin; AZD2171, IND# 72740, NSC# 732208) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Phase 2
18 Years
Open (Enrolling)
Endometrial Adenocarcinoma, Endometrial Adenosquamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Recurrent Endometrial Carcinoma

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Trial Information

A Phase II Evaluation of Cediranib (Recentin; AZD2171, IND# 72740, NSC# 732208) in the Treatment of Recurrent or Persistent Endometrial Carcinoma


I. To determine the response at 6 months of patients with persistent or recurrent
endometrial carcinoma treated with cediranib maleate.

II. To determine the progression-free survival at 6 months of patients treated with this

III. To determine the frequency and degree of toxicity of this regimen in these patients.


I. To determine the duration of progression-free survival of patients treated with this

II. To determine the duration of overall survival of patients treated with this regimen.

III. To estimate the probability of response without restriction on the duration of response
documentation of these patients since study enrollment.


I. To determine whether the response to cediranib maleate correlates with high-expression of
its receptor targets (e.g., VEGFR [1, 2, 3] and PDGFR).

II. To determine whether the response to cediranib maleate correlates with high endogenous
circulating plasma levels of VEGFA, low-levels of its endogenous inhibitor, sFlt-1 (the
truncated, circulating portion of VEGFR-1), or circulating Tissue Factor (TF) or circulating
Par-4, both potential markers of tumor progression.

III. To determine whether a high-expression of VEGFA on pre-treatment tumor specimens
correlates with response to this regimen.

IV. To determine whether expression of phosphorylated ERK1 and 2, c-Jun, Stat3, PKC, and
p70S6 kinase correlates with resistance or sensitivity to cediranib maleate.

OUTLINE: This is a multicenter study.

Patients receive oral cediranib maleate once daily on days 1-28. Treatment repeats every 28
days in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection at baseline and periodically
during study for biomarker and other analysis.

After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria:

- 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

- 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

- 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

- 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

- 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 blood pressure (BP) > 150 mm Hg
or diastolic BP > 100 mm Hg despite optimized antihypertensive therapy)

- Myocardial infarction or unstable angina within the past 6 months

- New York Heart Association (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 (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

- No concurrent amifostine or other protective reagents

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1

Outcome Time Frame:

At 6 months

Safety Issue:


Principal Investigator

David Bender

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

Related Keywords:

  • Endometrial Adenocarcinoma
  • Endometrial Adenosquamous Cell Carcinoma
  • Endometrial Clear Cell Carcinoma
  • Endometrial Papillary Serous Carcinoma
  • Recurrent Endometrial Carcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Adenosquamous
  • Adenocarcinoma, Clear Cell
  • Adenomyoepithelioma
  • Cystadenocarcinoma, Serous
  • Adenoma
  • Endometrial Neoplasms



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