Study on Biomarker-Driven Treatments for Persistent or Returning Rare Ovarian Tumors
Sponsor: Hoffmann-La Roche
ClinicalTrials ID:NCT04931342
This clinical trial is testing the effectiveness and safety of treatments chosen based on specific biomarkers in patients with rare types of ovarian, fallopian tube, or primary peritoneal tumors that have not responded to previous treatments or have returned.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to evaluate how well different treatments work and how safe they are for patients with rare types of ovarian, fallopian tube, or primary peritoneal tumors that have either persisted or come back after treatment. The trial will be conducted in two phases: an initial phase and a possible expansion phase, depending on the results.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of a rare type of ovarian, fallopian tube, or primary peritoneal cancer that is not high-grade serous or high-grade endometrioid.
- The cancer must be measurable by scans or tests.
- Have received one to four previous treatments, including at least one platinum-based chemotherapy.
- The cancer must have shown resistance to platinum-based treatments, meaning it progressed during or within six months after the last platinum treatment.
- Provide a tumor sample for genetic testing and estrogen receptor analysis.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have adequate blood counts and organ function.
- Women of childbearing potential must agree to use contraception or remain abstinent and not donate eggs during the study.
- Meet any additional specific criteria for the treatment arm they are assigned to.
Exclusion Criteria
- Pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study.
- Have cancer that progressed during or within four weeks after the first platinum treatment.
- Have high-grade serous or high-grade endometrioid ovarian, fallopian tube, or primary peritoneal cancer.
- Have only borderline ovarian tumors or non-epithelial ovarian tumors.
- Have another primary endometrial cancer, unless it meets specific low-risk criteria.
- Have uncontrolled fluid buildup around the lungs, heart, or abdomen that requires frequent drainage.
- Have untreated or worsening cancer that has spread to the brain or central nervous system.
- Have had a severe infection within four weeks before starting the study treatment.
- Have received chemotherapy, radiotherapy, or other specific treatments within 28 days before starting the study treatment.
- Have received hormonal therapy within 14 days before starting the study treatment.
- Must not meet any additional exclusion criteria specific to the treatment arm they are assigned to.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCSF Helen Diller Family CCC | 94158 | San Francisco | California |
| Washington University School of Medicine | 63108 | St Louis | Missouri |
| Levine Cancer Institute | 28204 | Charlotte | North Carolina |
| Ohio State University | 43210 | Columbus | Ohio |
| University of Oklahoma Health Sciences Center | 73104 | Oklahoma City | Oklahoma |
| Texas Oncology - Gulf Coast | 77380 | The Woodlands | Texas |
| Virginia Oncology Associates | 23502 | Norfolk | Virginia |
| University of Washington - Seattle Cancer Care Alliance | 98109 | Seattle | Washington |
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