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A Phase II Study of Postoperative Intensity Modulated Radiation Therapy (IMRT) With Concurrent Cisplatin and Bevacizumab Followed by Carboplatin and Paclitaxel for Patients With Endometrial Cancer

Phase 2
18 Years
Not Enrolling
Endometrial Adenocarcinoma, Endometrial Adenosquamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Stage I Endometrial Carcinoma, Stage II Endometrial Carcinoma, Stage III Endometrial Carcinoma, Stage IV Endometrial Carcinoma

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Trial Information

A Phase II Study of Postoperative Intensity Modulated Radiation Therapy (IMRT) With Concurrent Cisplatin and Bevacizumab Followed by Carboplatin and Paclitaxel for Patients With Endometrial Cancer


I. To assess the treatment-related, grade 3+, non-hematologic adverse-event rate within 90
days from the start of treatment with concurrent intensity-modulated radiotherapy,
cisplatin, and bevacizumab followed by carboplatin and paclitaxel in patients with high-risk
endometrial cancer.


I. To evaluate treatment-related adverse events occurring within 1 year from the start of

II. To evaluate all treatment-related adverse events. III. To evaluate disease-free and
overall survival. IV. To evaluate local, regional, and distant failure.

OUTLINE: This is a multicenter study.

Patients undergo pelvic intensity-modulated radiotherapy (IMRT) once daily, 5 days a week,
for 5 weeks. Patients may also undergo optional nodal boost radiotherapy and/or vaginal
brachytherapy boost. Patients also receive concurrent cisplatin IV over 1 hour on days 1 and
29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after
completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin IV over 1 hour and
paclitaxel IV over 3 hours on day 1. Treatment with carboplatin and paclitaxel repeats every
21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year,
every 6 months for 2 years, and then annually thereafter.

Inclusion Criteria:

- Histologically confirmed endometrial cancer, including 1 of the following cellular

- Endometrioid endometrial adenocarcinoma

- Clear cell carcinoma

- Papillary serous adenocarcinoma

- Adenosquamous cell carcinoma

- Other adenocarcinoma variant

- No carcinosarcoma

- Meets 1 of the following criteria:

- Grade 3 carcinoma with > 50% myometrial invasion (stage IC or IIA) (all
papillary serous or clear cell carcinoma will be considered grade 3)

- Grade 2 or 3 carcinoma with any cervical stromal invasion (stage IIB)

- Known extra-uterine disease confined to the pelvis (stage III or IVA)

- Patients with stage III or IVA disease must have undergone CT scan or
PET/CT scan of the abdomen and pelvis within the past 56 days

- Has undergone hysterectomy (i.e., total abdominal, vaginal, robotic-assisted,
radical, or laparoscopic-assisted vaginal hysterectomy) and bilateral
salpingo-oophorectomy within the past 56 days

- No positive common iliac or positive para-aortic nodal disease (defined as lymph
nodes ≥ 2 cm in any dimension on CT scan or biopsy) or positive peritoneal cytology

- No evidence of metastatic extrauterine disease, gross or residual disease (not
including pelvic nodal disease), or distant metastases

- Zubrod performance status 0-1

- ANC ≥ 1,500/mm^3 (without growth factor support)

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 g/dL (transfusion allowed)

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2 times ULN

- Serum creatinine ≤ 1.5 mg/dL

- Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg on 24-hour urine

- INR < 1.5 (for patients treated with warfarin within the past 14 days)

- Not nursing

- No neuropathy ≥ CTCAE grade 1

- No ototoxicity > CTCAE grade 2

- No serious, active comorbidity, including any of the following:

- Unstable angina and/or NYHA class II-IV congestive heart failure requiring
hospitalization within the past 12 months

- Transmural myocardial infarction within the past 12 months

- Acute bacterial or fungal infection requiring IV antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- AIDS based upon current CDC definition (HIV testing is not required)

- Active gastrointestinal (GI) ulcers, GI bleeding, inflammatory bowel disease, or
GI obstruction

- Inadequately controlled hypertension, defined as systolic BP > 150 mm Hg and/or
diastolic BP > 90 mm Hg on antihypertensive medications

- Significant vascular disease, including aortic aneurysm, aortic dissection, or
arteriovenous malformation within the past 12 months

- Serious cardiac arrhythmia on medication (well-controlled atrial fibrillation on
medication allowed)

- Serious non-healing wound, ulcer, or bone fracture

- No history of hypertensive crisis or hypertensive encephalopathy

- No stroke/cerebrovascular event within the past 12 months

- No arterial thromboembolic events, including transient ischemic attack or clinically
symptomatic peripheral artery disease within the past 12 months

- No abdominal fistula, GI perforation, or intra-abdominal abscess within the past 6

- No other invasive malignancies within the past 3 years other than nonmelanomatous
skin cancer

- No significant trauma within the past 28 days

- No mental status changes or bladder problems that would preclude the ability to
comply with bladder-filling instructions

- No mental or psychiatric illness that would preclude giving informed consent

- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human antibodies

- No prior allergic reaction to bevacizumab, cisplatin, carboplatin, or paclitaxel

- No concurrent erythropoietin, St. John's wort, therapeutic anticoagulants,
aminoglycoside antibiotics, or amifostine

- No prior organ transplantation

- No prior external-beam radiotherapy to the pelvis resulting in overlapping of
radiotherapy fields

- No prior systemic chemotherapy for uterine cancer

- Prior chemotherapy for a different cancer is allowed

- No prior therapy with anti-VEGF compounds

- More than 28 days since prior major surgical procedure requiring open biopsy incision

- No concurrent surgery (except for vascular access device placement or procedures that
do not require significant incision)

- No concurrent warfarin at doses > 1 mg/day

- Concurrent prophylactic low molecular weight heparin allowed

Type of Study:


Study Design:

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

Outcome Measure:

Treatment-related, grade 3+, non-hematologic adverse events as assessed by NCI CTCAE v4.0

Outcome Time Frame:

Up to 90 days

Safety Issue:


Principal Investigator

Akila Viswanathan

Investigator Role:

Principal Investigator

Investigator Affiliation:

American College of Radiology Imaging Network


United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

Related Keywords:

  • Endometrial Adenocarcinoma
  • Endometrial Adenosquamous Cell Carcinoma
  • Endometrial Clear Cell Carcinoma
  • Endometrial Papillary Serous Carcinoma
  • Stage I Endometrial Carcinoma
  • Stage II Endometrial Carcinoma
  • Stage III Endometrial Carcinoma
  • Stage IV Endometrial Carcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Endometrial Neoplasms
  • Carcinoma, Adenosquamous
  • Adenocarcinoma, Clear Cell
  • Adenomyoepithelioma
  • Cystadenocarcinoma, Serous
  • Adenoma



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