Clinical trial · Interventional
Pharmacokinetic Study of Avastin and Doxil in Ovarian Cancer
Phase II and Pharmacokinetic Study of Avastin and Doxil in the Treatment of Platinum-resistant or Refractory Ovarian Cancer
NCT00846612CI-TRIAL-00040912completedPhase 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)
This study is to study pharmacokinetics of Doxil using Doxil and Avastin on ovarian cancer patients who are resistant to or have relapsed from platinum-based therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab (Avastin) | Drug | Bevacizumab | ALIAS |
| Doxil | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Avastin-Doxil
- interventionNames
- Drug: Doxil
- Drug: Bevacizumab (Avastin)
Primary outcomes (1)
- measure
- change in peak plasma concentration of Doxil without and with Avastin
- timeFrame
- 1 hour, 1, 4, 7, 10, 14, and 21 days post-dose in cycle 1 and cycle 2
- description
- In cycle 1, patients were treated only with Doxil; in cycle 2, patients were treated with Doxil and Avastin.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients must be platinum resistant
* No prior anthracycline use
* PS ≤ 2
* Lab values within certain limits (ANC \> 1000, platelets \> 100,000; ALT, AST 2x ULN, creatinine \< 2.0);
* No more than 3 prior chemotherapy regimens, only 2 of which can have included platinum-containing regimens.
* Use of effective means of contraception in subjects of child-bearing potential
Exclusion Criteria:
* Disease-Specific Exclusions:
* Evidence of complete or partial bowel obstruction
* Need for IV hydration or TPN
* \> 2 prior abdominal surgeries
* History of gastrointestinal perforation
* Gastrointestinal perforation due to any other cause within the last 6 months
* General Medical Exclusions:
* Inability to comply with study and/or follow-up procedures
* Life expectancy of less than 12 weeks
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
* Avastin-Specific Exclusions:
* Inadequately controlled hypertension (defined as systolic blood pressure greater than 150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications)
* Any prior history of hypertensive crisis or hypertensive encephalopathy
* New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E of the protocol)
* History of myocardial infarction or unstable angina within 6 months prior to study enrollment
* History of stroke or transient ischemic attack within 6 months prior to study enrollment
* Known CNS disease
* Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
* Symptomatic peripheral vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
* History of abdominal fistula, or intra-abdominal abscess within 6 months prior to study enrollment
* Serious, non-healing wound, ulcer, or bone fracture
* Proteinuria at screening as demonstrated by either
* Urine protein:creatinine (UPC) ratio no less than 1.0 at screening OR
* Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
* Known hypersensitivity to any component of Avastin
* Pregnant (positive pregnancy test) or lactating. No effective means of contraception (men and women) in subjects of child-bearing potentialReferences
Publications (0)
Data not yet available
No reference posted for this study.