Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00408070
Other study ID # AVF 3696s
Secondary ID IRB 06-337-1
Status Terminated
Phase Phase 2
First received December 5, 2006
Last updated February 6, 2018
Start date October 2006
Est. completion date October 2009

Study information

Verified date February 2018
Source UConn Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to determine whether the addition of bevacizumab to a regimen of carboplatin plus paclitaxel significantly improves Progression Free Survival (PFS) for patient with Stage III suboptimally cytoreduced or Stage IV ovarian, primary peritoneal or fallopian tube carcinomas.


Description:

The aim of this study is to determine if the addition of bevacizumab to a regimen of carboplatin/paclitaxel increases the time to disease recurrence (longer remission for patients) in women that have Stage III suboptimally reduced or Stage IV ovarian cancer.

The hypothesis is that the addition of bevacizumab to a carboplatin/paclitaxel regimen will increase progression free survival in subjects that have Stage III suboptimal cytoreduced or Stage IV ovarian cancer.

Scientific Background and Significance: Vascular endothelial growth factor (VEGF) is found in most tissues, and is known to regulate angiogenesis in both normal (e.g. ovulation) and abnormal (e.g. malignant tumors) conditions. VEGF has been found to be overexpressed in several tumor types, including breast, bladder, uterine, cervical, and relevant to this application, primary and metastatic tumors of patients with advanced ovarian cancer. It is widely believed that the overexpression of this factor contributes to tumorigenesis by supplying a conduit through which oxygen and nutrients can reach and feed the growing malignancy.

Treatment with an anti-VEGF antibody may help to exert a direct anti-angiogenic effect by binding to and clearing VEGF from the tumor microenvironment, thus preventing the formation of new blood vessels. Bevacizumab is a recombinant humanized anti-VEGF monoclonal antibody that inhibits the growth of a number of human cancers, including ovarian cancer. Additional antitumor activity may be obtained through the effects of bevacizumab on tumor vasculature, interstitial pressure, and blood vessel permeability, all of which could allow for enhanced delivery of concurrently administered chemotherapeutic agents to tumor cells.

Based on preliminary data (Proc Am Soc Clin Oncol 2005; 23:A5000 and A 5009), there is biologic rationale to use bevacizumab in the treatment of advanced ovarian cancer. These 2 preliminary studies reported an improved progression-free survival in patients with recurrent ovarian cancer with the use of bevacizumab in combination with chemotherapy. Based on this activity in the recurrent setting, the activity of bevacizumab needs to be evaluated in chemotherapy-naïve patients with advanced ovarian cancer. The purpose of this clinical trial is to determine whether the addition of bevacizumab to a regimen of carboplatin and paclitaxel significantly improves Progression Free Survival (PFS) in patients with Stage III suboptimally cytoreduced or Stage IV ovarian, primary peritoneal or fallopian tube carcinomas.

It is apparent that newer innovative therapies are needed in the front line setting to decrease recurrences and improve survival. The addition of bevacizumab, the anti-vascular endothelial growth factor antibody, to the standard carboplatin/taxol treatment paradigm might help to increase the long-term survival rates in patients newly diagnosed with advanced suboptimal ovarian cancer. The proposed study addresses this issue. The investigational plan that will be utilized to test the hypothesis that the addition of bevacizumab extends the survival time of the affected patients is outlined below.

Women with Stage III or IV ovarian cancer/primary peritoneal cancer/fallopian tube cancer that have undergone surgery with residual suboptimally cytoreduced disease (suboptimal defined as >1cm disease) will be eligible for treatment with one 21-day cycle of carboplatin and paclitaxel and five 21-day cycles of bevacizumab, carboplatin and paclitaxel for a total of six treatment cycles; bevacizumab treatment is delayed by one cycle to ensure adequate post-surgical healing. Subjects will be evaluated by CT scans to determine response to therapy; individuals that progress will be withdrawn from the study. The CT scan conducted after the completion of therapy will dictate the next course of action. Patients demonstrating a complete response will be maintained on bevacizumab as consolidation therapy; subjects demonstrating a partial response will continue to receive bevacizumab, carboplatin and paclitaxel. The total treatment time for patients with a clinical response following the initial 6 cycles of therapy will be 12 months. Prior to starting consolidation therapy, all patients with a complete clinical response or in those for whom surgery may result in a complete secondary cytoreduction, will be given the option of undergoing a second look surgery. The findings at surgery in combination with the CT scan will determine the response to initial therapy. The decision not to participate in the second look surgery will not affect the follow-up treatment that the patient will receive.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date October 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Female
Age group 19 Years and older
Eligibility Inclusion Criteria:

- diagnosis of primary peritoneal carcinoma, fallopian tube epithelial ovarian carcinoma,

- stage III suboptimal surgery or biopsy,

- stage IV disease

- no prior chemotherapy

Exclusion Criteria:

- unstable heart conditions

- high blood pressure

- vascular disorders

- bleeding problems

Study Design


Intervention

Drug:
Bevacizumab
cycle 2 (6 cycles re-evaluated and follow up)
Carboplatin
cycle #1 and continuous through entire regimen; treated every 3 weeks
Paclitaxel
cycle #1 and continuous through entire regimen; treated every 3 weeks

Locations

Country Name City State
United States University of Connecticut Health Center Farmington Connecticut

Sponsors (2)

Lead Sponsor Collaborator
UConn Health Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival Rate at 9 Months This Outcome is measuring the number of particpants who have survived. 9 months
Secondary Response to Treatment (Clinical/Pathological) 12 months
Secondary Rate of Decline of CA-125 12 months
Secondary To Determine the Degree and Type of Toxicity of This Combined Regimen weekly
Secondary Determine Tolerability to 12 Months (q 3 Weeks) of Bevacizumab Maintenance Therapy 12 months
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2