Clinical trial · Interventional
(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma
Platinum-Gemcitabine-Avastin (PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma
NCT01936974CI-TRIAL-00031728PGAterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI Decision
Summary
Brief summary (as posted)
To evaluate progression-free survival with two chemotherapy regimens on platinum-resistant/refractory ovarian and peritoneal carcinoma
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 Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Peritoneal Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Platinum, Gemcitabine and Bevacizumab
- description
- Platinum: 1. Carboplatin\* on day 1 \*If a patient is allergic to carboplatin, then give 2. Cisplatin\*\* on day 1 \*\*If a patient is allergic to cisplatin and carboplatin, then give 3. Oxaliplatin on day 1 Gemcitabine on day 1 only Bevacizumab on day 1
- interventionNames
- Drug: Gemcitabine
- Drug: Bevacizumab
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Oxaliplatin
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine and Bevacizumab
- description
- Gemcitabine on days 1 and 8 Bevacizumab on day 1
- interventionNames
- Drug: Gemcitabine
- Drug: Bevacizumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients ≥ 18 years of age with histologically confirmed, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer 2. Disease progression during or within 6 months of previous platinum-based chemotherapy including the following 4 categories: 1. Primary platinum-refractory: Previously untreated patients who do not achieve at least a partial response to platinum-based chemotherapy 2. Primary platinum-resistant: Previously untreated patients who have achieved at least a partial response to platinum-based chemotherapy but experience a relapse within a period of 6 months of its conclusion 3. Secondary platinum-refractory: Previously treated patients have a relapse 6 months after the conclusion of chemotherapy, but fail to achieve at least a partial response 4. Secondary platinum-resistant: Previously treated patients have a relapse 6 months after the conclusion of chemotherapy, achieve at least a partial response with platinum-based therapy as 2nd-line therapy, but experience relapse within 6 months 3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2 and a life expectancy \>3 months. 4. Absolute neutrophil count \> 1500 mm\^3, platelet count ≥ 100×10\^9 L, hemoglobin ≥ 8.5 g/dL 5. Serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range 6. No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator 7. At least three (3) weeks from prior chemotherapy Exclusion Criteria: 1. Inadequate renal function with a calculated creatinine clearance less than 51 mL/min 2. Uncontrolled cardiac disease, congestive heart failure, angina, or hypertension 3. Myocardial infarction or unstable angina within 2 months of treatment 4. Known human immunodeficiency virus (HIV) infection or chronic active Hepatitis B or C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol) 5. Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks, pulmonary embolism within the past 6 months 6. Bleeding diathesis or significant coagulopathy 7. Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug 8. Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug 9. History of fistula, GI perforation, or intrabdominal abscess 10. Serious non-healing wound, ulcer, or bone fracture 11. clinical signs or symptoms of GI obstruction and/or requirement for parenteral hydration or nutrition 12. Known CNS disease except for treated brain metastasis 13. Known platinum drug allergy 14. Prior treatment with Platinum + Gemcitabine + Avastin, Gemcitabine + Avastin or Gemcitabine alone 15. Prior treatment with more than three (3) lines of chemotherapy including adjuvant chemotherapy 16. Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug 17. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements 18. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
References
Publications (0)
Data not yet available
No reference posted for this study.