Clinical trial · Interventional
Study of Intraperitoneal Carboplatin With IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer
Phase I Study of Intraperitoneal Carboplatin With Intravenous Paclitaxel and Bevacizumab in Patients With Previously Untreated Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma
NCT01220154CI-TRIAL-00086299completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Phase I study to evaluate intraperitoneal carboplatin along with weekly intravenous paclitaxel and bevacizumab in order to establish a tolerable dose and define the toxicity of this regimen in previously untreated patients with advanced ovarian carcinoma.
Conditions
Conditions (4)
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 Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| No Prior Chemotherapy | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carboplatin Paclitaxel & Bevacizumab
- description
- Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
- Every Cycle-28 days
- description
- The Maximum Tolerated Dose is defined as the highest dose at which no more than 1 of 6 evaluable patients experiences a dose limiting toxicity.
Secondary outcomes (1)
- measure
- Response Rate, Progression Free Survival and Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Histology diagnoses epithelial ovarian, primary peritoneal, or fallopian tube(Stage II, III or IV)either optimal or suboptimal after initial surgery. * All patients must have had appropriate surgery for ovarian, peritoneal, or fallopian tube carcinoma with tissue available for histologic evaluation * Histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant brenner tumor, adenocarcinoma NOS. * GOG(Gynecologic Oncology Group)performance status of 0,1,2 * Entered within 12 weeks of most recent surgery performed for diagnosis. * Patients must have adequate bone marrow function, renal function,hepatic function, neurologic function, blood coagulation parameters within normal limits * Sign approved consent form. Exclusion Criteria: * Patients who have received prior treatment other than initial surgery * Patients who have received prior radiotherapy to any portion of their abdominal cavity or pelvis * Patients with acute hepatitis or active infection * Patients with active bleeding * Patients with unstable angina * Patients with history of invasive malignancies with the exception of nonmelanoma skin cancer and localized breast cancer. * Patients who have received any target therapy or hormonal therapy for management of their ovarian cancer. * Patients with synchronous primary endometrial cancer. * Patients with epithelial tumors of low malignant potential * Serious non healing wound, ulcer or bone fracture. * Patients with history or evidence of CNS(central nervous system disease) * Patients under 18 years old. * Patients who have received prior therapy with anti-VEGF(vascular endothelial growth factor) drug, bevacizumab * Patients who have a history of allergic reaction to polysorbate 80.
References
Publications (0)
Data not yet available
No reference posted for this study.