Clinical trial · Interventional
Study of Revlimid With Doxil and Avastin for Patients With Platinum Resistant Ovarian Cancer
Phase IB Study of Lenalidomide (Revlimid®) With Liposomal Doxorubicin (Doxil®) and Bevacizumab (Avastin®) for Patients With Platinum Resistant Ovarian Cancer.
NCT01202890CI-TRIAL-00013354terminatedPhase 1ClinicalTrials.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): Terminated due to inadequate rate of accrual.
Summary
Brief summary (as posted)
This study will test the feasibility of combining 3 drugs, Revlimid with Doxil and Bevacizumab,and gather preliminary data on the potential activity of the combination in patients with platinum resistant/refractory ovarian cancer.
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 |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide, Liposomal Doxorubicin, Bevacizumab | Drug | — | UNRESOLVED |
| Revlimid, Doxil, Avastin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- At the expansion phase: Revlimid 20 mg (days 1-21), Doxil 30 mg/m2 on Day 1 and Avastin 15 mg/kg on Day 1, every 3 weeks. If this regimen is not cumulatively tolerable, Avastin will be administered every other course. Patients will be received up to 6 cycles or disease progression, followed by Revlimid maintenance at 25 mg PO q Day for 3 weeks every 4 weeks in patients with stable disease.
- interventionNames
- Drug: Lenalidomide, Liposomal Doxorubicin, Bevacizumab
- Drug: Revlimid, Doxil, Avastin
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of the 3 drug combination and recommend a dose for phase II studies.
- timeFrame
- 6-8 months
Secondary outcomes (2)
- measure
- Progression-free survival (PFS) after treatment with Revlimid plus Avastin and Doxil.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * EOC patients must be platinum resistant/refractory (see 1.1 for definition) and be considered by the attending physician capable of being treated in this study according to GCP. * Measurable disease by RECIST criteria or evaluable disease by GCIC criteria * No prior anthracycline or lenalidomide use, unless the dose received was equal or less than one cycle and the patient did not progress on treatment. * Subjects must have calculated creatinine clearance \> 60ml/min by Cockcroft-Gault formula during the escalation phase. * Subjects must have calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula during the expansion phase. See section below, "Dosing Regimen", regarding lenalidomide dose adjustment for calculated creatinine clearance \> 30ml/min and \< 60ml/min. * Understand and voluntarily sign an informed consent form. * All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. * Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control. * No contraindication to anticoagulation Exclusion Criteria: * Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). * Concurrent use of other anti-cancer agents or treatments. * Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. * History of thromboembolic event within the last 3 months * Known hypersensitivity to any component of Avastin
References
Publications (0)
Data not yet available
No reference posted for this study.