Clinical trial · Interventional
A Study of Carboplatin and DOXIL Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
A Phase II Single Arm Study of Carboplatin and DOXIL (PLD) Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. All patients will received DOXIL, carboplatin and bevacizumab for a maximum of ten 28-day cycles. Patients will be followed for six months following treatment to assess progression-free survival.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Neoplasms | Fallopian Tube Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Peritoneal Neoplasms | Peritoneal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin HCL liposome; bevacizumab; carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 001
- description
- doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
- interventionNames
- Drug: doxorubicin HCL liposome; bevacizumab; carboplatin
Primary outcomes (1)
- measure
- The Primary Efficacy End Point is the Number of Patients With an Objective Response.
- timeFrame
- Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days)
- description
- Objective Response Rate to Treatment is defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR). A Complete Response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer * Relapse-free interval of \>6 months afer completion of first line platinum-based chemotherapy * Measurable disease (at least one lesion that can be accurately measured in a least 1 dimension) * Adequate bone marrow function, renal, and liver function. Normal cardiac function * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Exclusion Criteria: * No patients who have received more than 1 previous regimen of chemotherapy (maintenance is not considered a second regimen) * No patients receiving immunotherapy or radiotherapy or patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis * No patients who require parenteral hydration or nutrition or have clinical signs or symptoms of gastrointestinal bowel obstruction or perforation * No patients with previous or current malignancy other than basal cell or squamous cell carcinoma of the skin * No patients with clinically significant cardiovascular disease * No patients with a history of bevacizumab or other VEGF or VEGF receptor-targeted agent use.
References
Publications (0)
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