Study on Pegylated Liposomal Doxorubicin with Atezolizumab and/or Bevacizumab for Treating Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02839707
This clinical trial is exploring how well a combination of chemotherapy and immunotherapy drugs work in treating ovarian, fallopian tube, or primary peritoneal cancer that has returned after treatment. The study aims to find out which combination of these drugs is most effective in controlling the cancer.
Patient Parameters
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Program Overview
This study is testing the effectiveness of a combination of drugs, including pegylated liposomal doxorubicin (a chemotherapy drug), atezolizumab (an immunotherapy drug), and bevacizumab (another immunotherapy drug), in treating ovarian, fallopian tube, or primary peritoneal cancer that has come back. The goal is to see which combination works best to stop the cancer from growing and spreading.
Description
The study is divided into two phases: Phase II and Phase III.
In Phase II, the main goal is to estimate the likelihood of side effects after the first cycle of treatment and to compare how long patients live without the cancer getting worse when treated with different drug combinations.
In Phase III, the study will further compare the effectiveness of the treatments in terms of survival and cancer progression.
Secondary goals include evaluating the response rate to the treatments, the frequency and severity of side effects, and patient-reported outcomes related to symptoms and quality of life.
The study also involves collecting tissue and blood samples to explore how certain biomarkers might predict treatment outcomes.
Participants will be randomly assigned to one of three treatment groups:
- Group 1: Receives pegylated liposomal doxorubicin and atezolizumab.
- Group 2: Receives pegylated liposomal doxorubicin, bevacizumab, and atezolizumab.
- Group 3: Receives pegylated liposomal doxorubicin and bevacizumab.
All treatments are given in cycles every 28 days, as long as the cancer does not progress and side effects are manageable. After completing the study treatment, participants will have follow-up visits every 3 months for up to 2 years, and then every 6 months for up to 3 years.
Eligibility Criteria
Inclusion Criteria
- Must be able to complete the study requirements and follow-up.
- Women of childbearing potential must use effective birth control during the study and for 5 months after the last dose.
- Must provide a tumor tissue sample for analysis.
- Must have high-grade ovarian cancer or related types.
- Cancer must have returned within 6 months after finishing platinum-based therapy.
- Must have had 1-2 prior treatment regimens.
- Must have measurable or evaluable disease.
- Must be 18 years or older.
- Must have a performance status score of 0, 1, or 2.
- Must meet specific blood count and organ function criteria.
- Must provide informed consent before starting the study.
Exclusion Criteria
- Previous bone marrow or organ transplant.
- Recent systemic anticancer therapy or hormonal therapy.
- Previous treatment with certain immunotherapy drugs.
- Previous treatment with bevacizumab for platinum-resistant recurrence.
- Previous treatment with pegylated liposomal doxorubicin.
- Recent abdominal or pelvic radiotherapy.
- Unresolved side effects from previous treatments.
- Recent use of investigational drugs or certain immunosuppressive medications.
- Active or untreated brain metastases.
- Severe allergies to study drugs.
- Significant liver disease or autoimmune diseases.
- Active infections or recent major surgery.
- Pregnant or breastfeeding women.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| CTCA at Western Regional Medical Center | 85338 | Goodyear | Arizona |
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