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Monoclonal Antibodies

Paclitaxel + Carboplatin + Avastin for Peritoneal Neoplasm

Phase 1
Waitlist Available
Led By Richard T Penson, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment until the time of death, up to 20 years
Awards & highlights

Study Summary

The goal of this clinical research study is to learn about the safety and tolerability of paclitaxel and carboplatin when given in combination with Avastin to patients with ovarian, primary peritoneal, or fallopian tube cancer. Objectives: Primary study goals: To investigate the safety and tolerability of carboplatin and paclitaxel administered IP in combination with IV Avastin To determine if Avastin influences the pharmacokinetics of IP administered chemotherapeutic agents Secondary study goals: To determine the systemic exposure to paclitaxel and carboplatin during initial and late cycles of IP dosing. To collect overall survival (OS) and progression-free survival (PFS) To determine changes in IP VEGF levels To determine site of first recurrence Information on CA-125 response and clinical response will be descriptive as secondary goals of this study Exploratory goal: To estimate proportion of patients completing entire course of treatment

Eligible Conditions
  • Peritoneal Neoplasm
  • Ovarian Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment until the time of death, up to 20 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of treatment until the time of death, up to 20 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients Who Complete Entire Treatment Course
Systemic Exposure to Paclitaxel and Carboplatin
Secondary outcome measures
Change in Intraperitoneal VEGF levels
Change in Plasma CA-125 Level
Clinical Response Rate
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Paclitaxel + Carboplatin + AvastinExperimental Treatment3 Interventions
Paclitaxel Cycle 1 = 60 mg/m^2 IV weekly over 1 hour x 3 weeks; Cycles 2-6 = 60 mg/m^2 IP weekly over 1 hour x 3 weeks of each cycle. Carboplatin Cycle 1 = AUC 6 IV over 1 hour on day 1; Cycles 2-6 = AUC 6 IP over 1 hour on day 1 of each cycle. Avastin Cycle 2 = 15 mg/kg IV over 90 minutes on day 8; Cycles 3-6 = 15 mg/kg IV on day 1 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Bevacizumab
FDA approved
Carboplatin
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,596 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,279 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,643 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Patients With Carcinomas of Mullerian Origin
Richard Thomas Penson 2008. "Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Patients With Carcinomas of Mullerian Origin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00652119.
All > Acl
~3 spots leftby Apr 2025
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