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Epithelial Ovarian CancerPhase 2NCT02022917

Postoperative Adjuvant Chemotherapy With Bevacizumab and Maintenance Bevacizumab After Neoadjuvant Chemotherapy for Ovarian Cancer

A Phase 2 study testing Bevacizumab in people with Epithelial Ovarian Cancer, run by Chang Gung Memorial Hospital at 5 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to determine the feasibility of postoperative platinum-based chemotherapy plus adjuvant and maintenance bevacizumab after neoadjuvant chemotherapy followed by interval surgery in patients with extensive stage IIIC or IV ovarian, tubal, and peritoneal cancer. Read more about this study

Who is it for?
Ages 20 to 75 years, women only
Conditions the study is for
Epithelial Ovarian Cancer
What is being tested?
Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
5 sitesTaiwan
Study dates
Mar 2014to Jan 2021
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 20 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • previously untreated histologically proven epithelial ovarian cancer, tubal or peritoneal primary carcinoma, of FIGO stage IV or extensive stage III deem not feasible for primary cytoreductive surgery
  • histologic epithelial cell types as follows: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.).
  • well informed about the rationale of neoadjuvant chemotherapy as an alternative to upfront surgery followed by adjuvant chemotherapy and accepted treatment with three to four cycles of neoadjuvant treatment with three to four cycles of platinum-based regimen without progression followed by interval cytoreductive surgery
  • performance status of ECOG 0-2
  • adequate hematopoietic function is defined as below:
  • ANC ≥ 1,500/uL, equivalent to Common Toxicity Criteria for Adverse Events v4.03 (CTCAE) Grade1.
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  • Platelets ≥ 100,000/uL (CTCAE Grade 0-1).
  • INR is ≦ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and aPTT < 1.2 x ULN
  • adequate organ function is defined as below:
  • total bilirubin ≦ 1.5 × ULN (CTCAE Grade 1).
  • ALT/AST≦2.5 x ULN and alkaline phosphatase≦2.5 x ULN (CTCAE Grade 1)
  • serum creatinine ≦ 1.5 × ULN (CTCAE Grade 1).
  • adequate neurologic function, neuropathy (sensory and motor) ≦ CTCAE Grade 1
  • age 20-75 years old
  • Patients must have measurable and non-measurable disease. Patients may or may not have cancer-related symptoms.
  • life expectancy equal or longer than 3 months
  • Patients who have met the pre-entry requirements
  • ability to understand and willingness to sign a written informed consent document (within 3 weeks after interval surgery)

Who cannot join

  • borderline ovarian tumors, recurrent epithelial ovarian, tubal or peritoneal or non-epithelial cancers
  • history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarrachnoid hemorrhage within six months of the first date of treatment on this study.
  • Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded.
  • other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
  • patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their ovarian, peritoneal primary or fallopian tube carcinoma
  • patients with serious, non-healing wound, ulcer, or bone fracture.
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  • patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations.
  • history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months.
  • patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • clinically significant proteinuria. Urine protein should be screened by urine protein-creatinine ratio (UPCR). The UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection. Specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24 hour urine collection. Obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24 hour urine). Send sample to lab with request for urine protein and creatinine levels [separate requests]. The lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL) The UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL). Patients must have a UPCR < 1.0 to allow participation in the study.
  • clinical significant cardiovascular disease
  • Uncontrolled hypertension, defined as systolic >150 mm Hg or diastolic> 90 mm Hg.
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • active cardiac disease e.g. decompensated myocardial infarction within the 6-month period preceding entry into the study.
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • serious cardiac arrhythmia requiring medication.
  • CTCAE Grade 2 or greater peripheral vascular disease (at least brief (24 hrs) episodes of ischemia managed non-surgically and without permanent deficit)
  • History of CVA within six months.
  • known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • presence of other serious concomitant illness which can affect or elevate the value of CA-125, e.g.;
  • Autoimmune disease
  • Sarcoidosis
  • Chronic active hepatitis
  • Pericarditis
  • Cirrhosis of liver
  • Abdominal tuberculosis
  • Pancreatitis
  • acute hepatitis or active infection that requires parenteral antibiotics
  • anticipation of invasive procedures as defined below:
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of Bevacizumab therapy (cycle 2).
  • Major surgical procedure anticipated during the course of the study.
  • Core biopsy within 7 days prior to the first date of Bevacizumab therapy (cycle 2).
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
  • concurrent chemotherapy, radiotherapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
  • mental status is not fit for clinical trial
  • Patients who are pregnant or nursing. Subjects of child-bearing age have to use effective means of contraception
  • Patients who have received prior therapy with any anti-VEGF drug, including bevacizumab.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Taiwan5 sites

  • Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital

    Chiayi City

  • Department of Obstetrics & Gynecology Chang Gung Memorial Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • Wan Fang Hospital, Taipei Medical University,

    Taipei

  • Division of Gynecologic Oncology, Department of Obstetrics & Gynecology Chang Gung Memorial Hospital, Linkou Medical Center

    Taoyuan

Other trials in Taiwan

About this study

Official title: A Phase II Trial of Postoperative Platinum-based Chemotherapy Plus Adjuvant and Maintenance Bevacizumab After Neoadjuvant Chemotherapy Followed by Interval Surgery in Patients With Extensive Stage IIIC or IV Ovarian, Tubal, and Peritoneal Cancer

This study is to determine the feasibility of postoperative platinum-based chemotherapy plus adjuvant and maintenance bevacizumab after neoadjuvant chemotherapy followed by interval surgery in patients with extensive stage IIIC or IV ovarian, tubal, and peritoneal cancer.

Read the detailed description

This study is designed to determine the feasibility of administering adjuvant carboplatin, paclitaxel, and bevacizumab without unacceptable significant AE in patients with epithelial ovarian cancer after neoadjuvant carboplatin/cisplatin, and paclitaxel and interval cytoreductive surgery, primary peritoneal cancer or fallopian tube cancer. This study will also investigate progression free and to assess the quality of life.

A Simon minimax two-stage design is employed to determine permit early stopping when a moderately long sequence of initial adverse events occurs. Under this two-stage design, 13 subjects are enrolled at the first stage. If there are > 3 subjects discontinue treatment due to significant AE in the stage-1, then stop the trial. Otherwise, the second stage is implemented by including the other 14 subjects. The treatment safety will be evaluated and ensured by the occurrence rate of significant AE (or non AE). In stage-1, postoperative adjuvant cycles 2-6 will be observed for defined significant AE.

Patients' or physicians' decision of discontinuation not because of the above-defined significant AEs or due to cancer progression should not be counted as an end-point event.

Being tested
Bevacizumab
Keywords
ovarian cancer., tubal cancer, peritoneal cancer
Medical subject headings
Carcinoma, Ovarian Epithelial, Ovarian Neoplasms

What participants receive

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

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab 15 mg/ Kg (from post-op cycle 2) intravenous infusion for 30 minutes in a 21 days' cycle for at least three cycles (best to 6 cycles) followed by 3-weekly maintenance bevacizumab 15 mg/ Kg intravenous infusion for 17 cycles.

Study groups in NCT02022917
Study groupRoleWhat they receive
Epithelial Ovarian CancerExperimentalNeoadjuvant Carboplatin, Paclitaxel, and Bevacizumab 21 day cycles of carboplatin, paclitaxel, and bevacizumab
Receives: Drug: Bevacizumab

What is being measured

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

  1. Significant event rate of the regimen (neoadjuvant carboplatin, paclitaxel, and bevacizumab)

    Significant AEs include:

    1. Hypertension ≥ grade 3
    2. Proteinuria ≥ grade 3
    3. GI perforation, abscesses and fistulae (any grade)
    4. Wound healing complications ≥ grade 3
    5. Haemorrhage ≥ grade 3 (any grade CNS bleeding; ≥ grade 2 haemoptysis)
    6. Arterial thromboembolic events (any grade)
    7. Venous thromboembolic events ≥ grade 3
    8. PRES (any grade)
    9. CHF ≥ grade 3
    10. Non-GI fistula or abscess ≥ grade 2

    Measured: Up to 30 days after the last treatment

Secondary outcomes (1)

  1. Progression free survival (PFS)

    Following disease progression, the patient will be contacted every 26 weeks (+/- 2 weeks) (until 30 days after the last patient receives the last dose of bevacizumab) in order to capture their survival status

    Measured: Every 3 months during treatment and every 6 months for three years post-treatment

Timeline

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

  1. First posted30 Dec 2013 (estimated)
  2. Study startMar 2014
  3. Primary completionJan 2021
  4. Study completionJan 2021

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02022917
Sponsor's protocol ID
AGOG11-003
Other IDs
TGOG3008
Status last verified
Jan 2021
First submitted
11 Dec 2013
Last updated
27 Jan 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab in people with Epithelial Ovarian Cancer, run by Chang Gung Memorial Hospital at 5 sites in Taiwan.

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 18 inclusion and 37 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: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Taiwan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Significant event rate of the regimen (neoadjuvant carboplatin, paclitaxel, and bevacizumab) (time frame: Up to 30 days after the last treatment). 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 NCT02022917.

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 27 Jan 2021.

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