Clinical trial · Interventional
Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian
Phase I Evaluation of Intravenous Carboplatin With Weekly Paclitaxel and Bevacizumab in Patients Undergoing Neoadjuvant Chemotherapy for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
- 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 determine the maximum tolerated dose (MTD) of intravenous weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo surgery which will allow an objective measure of response to the above regimen as well as assessment of surgical outcomes.
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 Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| 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 (3)
- type
- EXPERIMENTAL
- label
- Carboplatin
- description
- AUC 5.0 or 6.0
- interventionNames
- Drug: carboplatin
- type
- EXPERIMENTAL
- label
- Bevacizumab
- description
- 15 mg/kg
- interventionNames
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- Paclitaxel
- description
- 60-80 mg/m2
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * histology,cytologically diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer * FIGO (International Federation of Gynecology and Obstetrics stage III or IV disease * GOG (Gynecologic Oncology Group) Performance Status 0,1,2 * No prior surgery for their malignancy * Adequate bone marrow function * Platelet count greater than or equal to 100,000 * Renal Function: Creatinine \< 1.5 institutional upper limit normal * Hepatic Function: Bilirubin less than 1.5 ULN (upper limit of normal) * Hepatic Function: SGOT (serum glutamate oxaloacetate transaminase) and Alkaline Phosphate * Neurologic Function: Neuropathy less than CTCAE (Common Toxicity Criteria for Adverse Effects)grade 1 * Coagulation Functions: INR\<1.5 and PTT ,1.2 times the upper limit of normal * Measurable disease Exclusion Criteria: * Previous cancer related surgery * Received prior chemotherapy, immunotherapy, radiotherapy, hormonal therapy or biologic therapy for their ovarian, fallopian tube or primary peritoneal cancer. * Borderline ovarian tumors, recurrent epithelial ovarian or primary peritoneal cancer or non-epithelial ovarian are not eligible. * Other cancers within 5 years (other than non-melanoma skin cancer) * Acute Hepatitis or end stage liver disease * History of prior gastrointestinal perforation * Evidence of abdominal free air not explained by paracentesis * Sign or symptoms of gastrointestinal obstruction * Active bleeding or pathologic conditions that carry high risk of bleeding * CNS (Central Nervous System) disease * Clinically Significant cardiovascular disease * Known hypersensitivity to Chinese Hamster ovary cell products or other recombinant human or humanized antibodies * Clinically significant proteinuria. * Hypertensive crises or hypertensive encephalopathy * History of hemoptysis * Any non-study related invasive procedure within 28 days fo first date of bevacizumab * GOG performance status 3 or 4 * Patients who are pregnant or nursing. * Under the age of 18 * Received prior treatment of bevacizumab or any anti-VEGF (vascular endothelial growth factor) drug
References
Publications (0)
Data not yet available