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Postoperative Adjuvant Chemotherapy With Bevacizumab and Maintenance Bevacizumab After Neoadjuvant Chemotherapy for Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT02022917•Chang Gung Memorial Hospital

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

20 - 75 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. 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
•2. 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.).
•3. 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
•4. performance status of ECOG 0-2
•5. adequate hematopoietic function is defined as below:
•* ANC ≥ 1,500/uL, equivalent to Common Toxicity Criteria for Adverse Events v4.03 (CTCAE) Grade1.
•* 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
•6. adequate organ function is defined as below:
•* total bilirubin ≦ 1.5 × ULN (CTCAE Grade 1).
+8 more criteria

Exclusion Criteria

•1. borderline ovarian tumors, recurrent epithelial ovarian, tubal or peritoneal or non-epithelial cancers
•2. 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.
•3. Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded.
•4. other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
•5. 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
•6. patients with serious, non-healing wound, ulcer, or bone fracture.
•7. patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations.
•8. history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months.
•9. patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
•10. 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.
+27 more criteria

Locations (5)

Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital

Chiayi City, Taiwan

Department of Obstetrics & Gynecology Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Wan Fang Hospital, Taipei Medical University,

Taipei, Taiwan

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

Taoyuan District, Taiwan

Key Dates

Start Date

March 1, 2014

Primary Completion Date

January 1, 2021

Completion Date

January 1, 2021

Last Updated

January 27, 2021

Enrollment

ACTUAL participants

Conditions

Epithelial Ovarian Cancer

Interventions

Bevacizumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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