A Study of Bevacizumab (Avastin) in Neoadjuvant Therapy in Participants With International Federation of Gynecology and Obstetrics (FIGO) Stage IIIC/IV Ovarian, Tubal, or Peritoneal Cancer, Initially Unresectable (ANTHALYA)

Roche

Status and phase: Completed; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01739218

2012-001144-22 (EudraCT Number)

ML28337

Details and patient eligibility

About

This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant bevacizumab in participants with initially unresectable, FIGO stage IIIC/IV ovarian, tubal, or peritoneal cancer. Participants will be randomized to receive 8 cycles of carboplatin plus paclitaxel with or without bevacizumab before surgery (interval debulking surgery [IDS]). Surgery will be scheduled 28 days after the last course of neoadjuvant treatment in participants with resectable cancer. Participants with unresectable cancer will go through the follow-up period. All participants will receive bevacizumab for Cycles 6 to 26.

Enrollment: 99 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed and documented high-risk FIGO stage IIIC/IV epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma
• Not eligible for primary complete debulking surgery during a laparoscopic procedure as judged by a surgeon experienced in management of ovarian cancer
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
• Life expectancy greater than or equal to (>/=) 3 months
• Eligible for carboplatin and paclitaxel chemotherapy in accordance with local standards
• Beneficiaries of healthcare coverage under the social security system

Exclusion criteria

• Non-epithelial ovarian cancer, ovarian tumor with low malignant potential, mucinous and clear cell ovarian cancer, or carcinosarcoma
• Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
• Previous systemic therapy for ovarian cancer
• Previous exposure to mouse CA-125 antibody
• Current or recent (within 28 days prior to Day 1 of Cycle 1) treatment with another investigational drug or previous participation in this study
• Current or recent (within 10 days prior to first study drug dose) chronic daily treatment with aspirin greater than (>) 325 milligrams (mg) per day
• Planned intraperitoneal cytotoxic chemotherapy
• Inadequate bone marrow, liver, or renal function
• History of myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to Day 1 of Cycle 1
• Uncontrolled hypertension
• Clinically significant (active) cardiovascular disease such as New York Heart Association (NYHA) Class II or greater congestive heart failure, or aortic aneurism
• Pre-existing peripheral neuropathy that is Common Toxicity Criteria (CTC) Grade >/=2
• Known hypersensitivity to bevacizumab or its excipients, Chinese hamster ovary cell products or other recombinant humanized antibodies, or to any planned chemotherapy
• Pregnant or lactating females
• History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix or breast

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Carboplatin + Paclitaxel + Bevacizumab

Experimental group

Description:

Participants will receive 4 cycles of neoadjuvant therapy prior to IDS and 22 cycles of adjuvant therapy before entering long-term follow-up. Each cycle will be 3 weeks in length. Carboplatin and paclitaxel will be administered during Cycles 1 to 8. Bevacizumab will be administered during both the neoadjuvant and the adjuvant treatment periods in Cycles 1 to 26 (no treatment in Cycles 4 and 5).

Treatment:

Drug: Carboplatin

Drug: Bevacizumab

Drug: Paclitaxel

Carboplatin + Paclitaxel

Active Comparator group

Description:

Participants will receive 4 cycles of neoadjuvant therapy prior to IDS and 22 cycles of adjuvant therapy before entering long-term follow-up. Each cycle will be 3 weeks in length. Carboplatin and paclitaxel will be administered during Cycles 1 to 8. Bevacizumab will be administered only during the adjuvant treatment period in Cycles 6 to 26.

Treatment:

Drug: Carboplatin

Drug: Bevacizumab

Drug: Paclitaxel