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
Overview
- Phase
- Phase 2
- Intervention
- Bevacizumab
- Conditions
- Epithelial Ovarian Cancer
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 22
- Locations
- 5
- Primary Endpoint
- Significant event rate of the regimen (neoadjuvant carboplatin, paclitaxel, and bevacizumab)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Chyong-Huey Lai
M.D.
Chang Gung Memorial Hospital
Eligibility Criteria
Inclusion Criteria
- •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) Grade
- •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).
Exclusion Criteria
- Not provided
Arms & Interventions
Epithelial Ovarian Cancer
Neoadjuvant Carboplatin, Paclitaxel, and Bevacizumab 21 day cycles of carboplatin, paclitaxel, and bevacizumab
Intervention: Bevacizumab
Outcomes
Primary Outcomes
Significant event rate of the regimen (neoadjuvant carboplatin, paclitaxel, and bevacizumab)
Time Frame: Up to 30 days after the last treatment
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
Secondary Outcomes
- Progression free survival (PFS)(Every 3 months during treatment and every 6 months for three years post-treatment)