AzTrials
AzTrials

Stage III-IV or Recurrent Endometrial CancerPhase 2MITOBEVAEND2NCT01770171

Carboplatin-Paclitaxel ± Bevacizumab in Advanced (Stage III-IV) or Recurrent Endometrial Cancer

A Phase 2 study testing Bevacizumab and Carboplatin AUC 5+Paclitaxel 175 mg/mq q 21 for 6-8 cycles in people with Stage III-IV or Recurrent Endometrial Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Wright et al (Anticancer Res, 2000) reported the results of a retrospective study on 11 patients with advanced/recurrent endometrial cancers. All patients had multi-site disease and were heavily pretreated with a median of 3 prior chemotherapy regimens. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bevacizumab and Carboplatin AUC 5+Paclitaxel 175 mg/mq q 21 for 6-8 cycles
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteItaly
Study dates
Apr 2012to Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years of age.
  • ECOG Performance Status of 0-2.
  • Life expectancy of at least 12 weeks.
  • Patients must have advanced stage III or IV, or recurrent histologically-confirmed endometrial cancer.
  • Endometrial cancer will include all carcinomas, including endometrioid carcinoma, papillary serous carcinoma, clear cell carcinoma.
  • One previous chemotherapy lines is allowed if platinum free interval is more than six mounths (previous radiotherapy is allowed).
Show all 14Show fewer
  • 7 Measurable and not measurable disease. 8 Adequate renal and hepatic function, defined as:
  • 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 present)
  • 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.

Who cannot join

  • Previous cytotoxic chemotherapy.
  • Women who are pregnant or lactating.
  • Presence of brain or other central nervous system metastases.
  • Anticancer treatment within 4 weeks prior to randomization.
  • Ongoing toxicity associated with prior anticancer therapy.
  • 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.
Show all 25Show fewer
  • Another primary malignancy within the past five years (except for non-melanoma skin cancer and cervical carcinoma in situ).
  • Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (>325 mg/day).
  • 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 purposes.
  • Inadequate coagulation parameters:activated partial thromboplastin time (APTT) >1.5 xULN or INR >1.5.
  • Known HIV infection.
  • Known hepatitis B or C infection.
  • Concurrent treatment with immunosuppressive or investigational agents.
  • 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).
  • 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.
  • Myocardial infarction or unstable angina within _6 months prior to the first study treatment.
  • New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF).
  • Serious cardiac arrhythmia requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
  • Peripheral vascular disease _grade 3 (i.e.symptomatic and interfering with activities of daily living requiring repair or revision).
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first study treatment.
  • 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.
  • Serious active infection requiring i.v. antibiotics at enrolment.
  • Significant traumatic injury during the 4 weeks preceding the first dose of bevacizumab.
  • Known hypersensitivity to any of the study drugs or excipients (including cremophor and hamster Ovary cell products).
  • 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.

Trial locations and contacts

1 site in 1 country.

Catholic University of Sacred Heart . contact

+39 0630156279

Italy1 site, 1 recruiting

  • Catholic University of Sacred Heart Rome,

    Rome, Rome, 00100

    Recruiting

Other trials in Italy

About this study

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

Wright et al (Anticancer Res, 2000) reported the results of a retrospective study on 11 patients with advanced/recurrent endometrial cancers. All patients had multi-site disease and were heavily pretreated with a median of 3 prior chemotherapy regimens. All received bevacizumab combination therapy which was well-tolerated. Two patients had partial responses, 3 had stable disease, while 5 patients progressed. One subject was not assessable for response. The median progression-free interval was 5.4 months for the entire cohort and 8.7 months for those who achieved clinical benefit (PR or SD). The authors concluded that Bevacizumab was well-tolerated and displayed promising anti-neoplastic activity in patients with endometrial cancer.The rationale for combining anti-angiogenic agents, including anti-VEGF antibodies, with cytotoxic chemotherapy stems from a number of preclinical studies showing additive and synergistic anti-tumour activity in a number of solid tumour types. By combining VEGF-targeting agents such as bevacizumab with conventional chemotherapies, it is hoped that these agents will act synergistically, thereby enhancing their anti-tumour efficacy and controlling disease progression.

The addition of bevacizumab to chemotherapy has been shown to improve PFS and/or OS in a series of large, randomized Phase III clinical trials in a wide range of tumour types, including mCRC, non-squamous NSCLC, metastatic BC (mBC) and mRCC.

Being tested
Bevacizumab, Carboplatin AUC 5+Paclitaxel 175 mg/mq q 21 for 6-8 cycles
Keywords
endometrial cancer, recurrent endometrial cancer, bevacizumab
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Carboplatin AUC 5+ Paclitaxel 175 mg/mq+Bevacizumab 15 mg/kg q 21 for 6 -8 cycles + Bevacizumab 15 mg/kg

  • Carboplatin AUC 5+Paclitaxel 175 mg/mq q 21 for 6-8 cyclesDrug

    Carboplatin AUC 5+Paclitaxel 175 mg/mq q 21 for 6-8 cycles

Study groups in NCT01770171
Study groupRoleWhat they receive
Carboplatin-paclitaxel-bevacizumabExperimentalCarboplatin AUC 5+ Paclitaxel 175 mg/mq+Bevacizumab 15 mg/kg q 21 for 6 -8 cycles + Bevacizumab 15 mg/kg every 3 weeks until disease progression
Receives: Drug: Bevacizumab
carboplatin-paclitaxelActive comparatorCarboplatin AUC 5+Paclitaxel 175 mg/mq q 21 for 6-8 cycles
Receives: Drug: Carboplatin AUC 5+Paclitaxel 175 mg/mq q 21 for 6-8 cycles

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    • 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)

    Measured: 3 months

Secondary outcomes (4)

  1. Overall survival

    • Overall survival defined as the time from the date of randomization to the date of death

    Measured: 3 months

  2. Best target lesion response

    Best target lesion response, defined as best change in sum of the target lesions from baseline to disease progression.

    Measured: 6 months

  3. Duartion of Response

    Duration of response Safety and tolerability

    Measured: 3 months

  4. Quality of life

    Changes Quality of Life parameters as measured using EORTC QLQ-30 \& EORTC-QLQ-EN-24

    Measured: 3 cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2013 (estimated)
  2. Study startApr 2012
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01770171
Sponsor's protocol ID
MITOBEVAEND2
Acronym
MITOBEVAEND2
Status last verified
Dec 2012
First submitted
10 Dec 2012
Last updated
17 Jan 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab and Carboplatin AUC 5+Paclitaxel 175 mg/mq q 21 for 6-8 cycles in people with Stage III-IV or Recurrent Endometrial Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Catholic University of Sacred Heart . (+39 0630156279), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01770171.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in