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A Randomized Phase II Trial of Carboplatin-Paclitaxel Compared to Carboplatin-Paclitaxel-Bevacizumab in Advanced (Stage III-IV) or Recurrent Endometrial Cancer

Phase 2
18 Years
Open (Enrolling)
Stage III-IV or Recurrent Endometrial Cancer

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Trial Information

A Randomized Phase II Trial of Carboplatin-Paclitaxel Compared to Carboplatin-Paclitaxel-Bevacizumab in Advanced (Stage III-IV) or Recurrent Endometrial Cancer

Inclusion Criteria:

1. ≥18 years of age.

2. ECOG Performance Status of 0-2.

3. Life expectancy of at least 12 weeks.

4. Patients must have advanced stage III or IV, or recurrent histologically-confirmed
endometrial cancer.

5. Endometrial cancer will include all carcinomas, including endometrioid carcinoma,
papillary serous carcinoma, clear cell carcinoma.

6. One previous chemotherapy lines is allowed if platinum free interval is more than six
mounths (previous radiotherapy is allowed).

7 Measurable and not measurable disease. 8 Adequate renal and hepatic function, defined

- Total serum bilirubin ≤ institutional ULN unless patient has Gilbert's syndrome in
which case direct bilirubin must be < ULN for the institution.

- AST and/or ALT ≤ 2.5 x ULN for the institution. (or ≤ 5 x ULN if liver metastases are

- Alkaline phosphatase < 1.5 x ULN for the institution (if > 1.5 x ULN, then alkaline
phosphatase liver fraction must be < 1.5 ULN).

- Serum creatinine ≤ 1.5 x ULN for the institution (or calculated creatinine clearance
≥ 50 mL/min/1.73 m2) 9 Adequate bone marrow function, defined as:

- Total leukocytes ³ 3.0 x 109/L.

- ANC ³ 1.5 x 109/L.

- Platelet count ³ 100 x 109/L. Able to understand and give written informed consent.
10 Females of childbearing potential must have a negative serum pregnancy test within
7 days prior to study enrollment.

Exclusion Criteria:

1. Previous cytotoxic chemotherapy.

2. Women who are pregnant or lactating.

3. Presence of brain or other central nervous system metastases.

4. Anticancer treatment within 4 weeks prior to randomization.

5. Ongoing toxicity associated with prior anticancer therapy.

6. Inadequate recovery from any prior surgical procedure or having undergone any major
surgical procedure within 4 weeks prior to randomization. Patients who have
recovered from placement of a central venous access port within 2 weeks of Cycle 1
Day 1 will be considered eligible.

7. Another primary malignancy within the past five years (except for non-melanoma skin
cancer and cervical carcinoma in situ).

8. Current or recent (within 10 days prior to the first study drug dose) chronic daily
treatment with aspirin (>325 mg/day).

9. Current or recent (within 10 days prior to the first study drug dose) use of
full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic

10. Inadequate coagulation parameters:activated partial thromboplastin time (APTT) >1.5
xULN or INR >1.5.

11. Known HIV infection.

12. Known hepatitis B or C infection.

13. Concurrent treatment with immunosuppressive or investigational agents.

14. History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular
accident (CVA) / stroke or transient ischemic attack (TIA) or subarachnoid
haemorrhage within _6 months prior to the first study treatment).

15. Uncontrolled hypertension (sustained systolic >150 mm Hg and/or diastolic >100 mm Hg
despite antihypertensive therapy) or clinically significant (i.e. active)
cardiovascular disease, including.

16. Myocardial infarction or unstable angina within _6 months prior to the first study

17. New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF).

18. Serious cardiac arrhythmia requiring medication (with the exception of atrial
fibrillation or paroxysmal supraventricular tachycardia).

19. Peripheral vascular disease _grade 3 (i.e.symptomatic and interfering with activities
of daily living requiring repair or revision).

20. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to the first study treatment.

21. Non-healing wound, ulcer or bone fracture. Patients with granulating incisions
healing by secondary intention with no evidence of facial dehiscence or infection are
eligible but require three weekly wound examinations.

22. Serious active infection requiring i.v. antibiotics at enrolment.

23. Significant traumatic injury during the 4 weeks preceding the first dose of

24. Known hypersensitivity to any of the study drugs or excipients (including cremophor
and hamster Ovary cell products).

25. Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer,
etc.), physical examination or laboratory findings that may interfere with the
planned treatment, affect patient compliance or place the patient at high risk from
treatment related complications.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

• Progression-free survival, defined as the time from the date of randomization to the date of documented progressive disease, recurrence or death (whichever occurs first)

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Giovanni Scambia, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Catholic University of Sacred Heart


Italy: Ethics Committee

Study ID:




Start Date:

April 2012

Completion Date:

December 2017

Related Keywords:

  • Stage III-IV or Recurrent Endometrial Cancer
  • endometrial cancer
  • recurrent endometrial cancer
  • bevacizumab
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma