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Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Primary Purpose

Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
erlotinib hydrochloride
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer Recurrent or metastatic disease Measurable disease, defined as ≥ 1 unidimensionally measurable indicator lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan Must have received a platinum-containing chemotherapy regimen for primary disease Re-treatment with a platinum-based regimen required for patients who achieved a clinical complete response (CR) to primary therapy and then had a treatment-free interval > 12 months (i.e., platinum-sensitive) unless the patient developed a hypersensitivity to platinum Patients with a treatment-free interval < 12 months do not require prior chemotherapy for recurrent disease No evidence of CNS disease, including primary brain tumors or brain metastasis Performance status - ECOG 0-2 More than 3 months WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No history of bleeding diathesis SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastasis) Bilirubin normal INR ≤ 1.5 (3 if receiving warfarin) No history of esophageal varices Creatinine ≤ 1.5 mg/dL Creatinine clearance ≥ 60 mL/min Urine protein < 1+ Urine protein < 1,000 mg on 24-hour urine collection Urine protein:creatinine ratio < 1.0 No arterial thromboembolic event within the past 6 months, including any of the following: Transient ischemic attack Cerebrovascular accident Unstable angina pectoris Myocardial infarction No clinically significant peripheral artery disease No uncontrolled hypertension No New York Heart Association grade II-IV congestive heart failure No serious cardiac arrhythmia requiring medication No peripheral vascular disease ≥ grade 2 Not pregnant No nursing during and for ≥ 3 months after study participation Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 3 months after study participation No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs (e.g., Chinese hamster ovary cell products or recombinant humanized antibodies) No serious or non-healing wound, ulcer, or bone fracture No active infection requiring parenteral antibiotics No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No gastrointestinal tract disease resulting in an inability to take oral medication No significant traumatic injury within the past 28 days No known HIV positivity No prior bevacizumab See Disease Characteristics No more than 2 prior cytotoxic chemotherapy regimens for recurrent or refractory disease (i.e., failed to achieve a clinical CR after primary therapy) More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) More than 4 weeks since prior radiotherapy No prior radiotherapy to any indicator lesion unless disease has progressed since completion of radiotherapy More than 4 weeks since prior major surgical procedure or open biopsy More than 1 week since prior core biopsy No prior surgery affecting absorption No concurrent major surgery Recovered from prior therapy No prior vascular endothelial growth factor (VEGF) or an epidermal growth factor receptor (EGFR) directed therapy No prior erlotinib At least 30 days since prior investigational drugs More than 1 month since prior thrombolytic agents Concurrent warfarin allowed provided the following criteria are met: Patient is on a therapeutic stable dose of warfarin INR ≤ 3 No active bleeding or pathological condition that would confer a high risk of bleeding (e.g., tumor invading adjacent organs or major blood vessels or varices that are likely to bleed) No other concurrent investigational agents No other concurrent anticancer therapy

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (bevacizumab, erlotinib hydrochloride)

Arm Description

Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to 1 of the study drugs may continue treatment with the remaining study drug alone in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Response rate of patients treated with the combination of bevacizumab and OSI-774

Secondary Outcome Measures

Progression-free survival
Will be analyzed using the Kaplan-Meier estimator (Kaplan 1958), and median progression-free survival times and their associated 90% confidence intervals will be determined using the method described in Brookmeyer and Crowley (Brookmeyer 1982).
Median progression-free survival
Overall survival rates and median overall survival times and their associated 90% confidence intervals will be determined by the same methods.
Overall survival
Overall survival rates and median overall survival times and their associated 90% confidence intervals will be determined by the same methods.

Full Information

First Posted
August 2, 2005
Last Updated
May 13, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00126542
Brief Title
Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Official Title
A Phase II Trial of Bevacizumab (NSC# 704865) and OSI-774 (NSC# 718781) In Recurrent Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with recurrent or metastatic ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bevacizumab together with erlotinib may kill more tumor cells.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the response rate in patients with recurrent or metastatic ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with bevacizumab and erlotinib. SECONDARY OBJECTIVES: I. Determine the toxic effects of this regimen in these patients. II. Determine the median progression-free survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to 1 of the study drugs may continue treatment with the remaining study drug alone in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (bevacizumab, erlotinib hydrochloride)
Arm Type
Experimental
Arm Description
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to 1 of the study drugs may continue treatment with the remaining study drug alone in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Other Intervention Name(s)
CP-358,774, erlotinib, OSI-774
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate of patients treated with the combination of bevacizumab and OSI-774
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Will be analyzed using the Kaplan-Meier estimator (Kaplan 1958), and median progression-free survival times and their associated 90% confidence intervals will be determined using the method described in Brookmeyer and Crowley (Brookmeyer 1982).
Time Frame
Time from treatment commencement to disease progression or death, whichever comes first, assessed up to 5 years
Title
Median progression-free survival
Description
Overall survival rates and median overall survival times and their associated 90% confidence intervals will be determined by the same methods.
Time Frame
From start of treatment to time of progression, assessed up to 5 years
Title
Overall survival
Description
Overall survival rates and median overall survival times and their associated 90% confidence intervals will be determined by the same methods.
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer Recurrent or metastatic disease Measurable disease, defined as ≥ 1 unidimensionally measurable indicator lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan Must have received a platinum-containing chemotherapy regimen for primary disease Re-treatment with a platinum-based regimen required for patients who achieved a clinical complete response (CR) to primary therapy and then had a treatment-free interval > 12 months (i.e., platinum-sensitive) unless the patient developed a hypersensitivity to platinum Patients with a treatment-free interval < 12 months do not require prior chemotherapy for recurrent disease No evidence of CNS disease, including primary brain tumors or brain metastasis Performance status - ECOG 0-2 More than 3 months WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No history of bleeding diathesis SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastasis) Bilirubin normal INR ≤ 1.5 (3 if receiving warfarin) No history of esophageal varices Creatinine ≤ 1.5 mg/dL Creatinine clearance ≥ 60 mL/min Urine protein < 1+ Urine protein < 1,000 mg on 24-hour urine collection Urine protein:creatinine ratio < 1.0 No arterial thromboembolic event within the past 6 months, including any of the following: Transient ischemic attack Cerebrovascular accident Unstable angina pectoris Myocardial infarction No clinically significant peripheral artery disease No uncontrolled hypertension No New York Heart Association grade II-IV congestive heart failure No serious cardiac arrhythmia requiring medication No peripheral vascular disease ≥ grade 2 Not pregnant No nursing during and for ≥ 3 months after study participation Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 3 months after study participation No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs (e.g., Chinese hamster ovary cell products or recombinant humanized antibodies) No serious or non-healing wound, ulcer, or bone fracture No active infection requiring parenteral antibiotics No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No gastrointestinal tract disease resulting in an inability to take oral medication No significant traumatic injury within the past 28 days No known HIV positivity No prior bevacizumab See Disease Characteristics No more than 2 prior cytotoxic chemotherapy regimens for recurrent or refractory disease (i.e., failed to achieve a clinical CR after primary therapy) More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) More than 4 weeks since prior radiotherapy No prior radiotherapy to any indicator lesion unless disease has progressed since completion of radiotherapy More than 4 weeks since prior major surgical procedure or open biopsy More than 1 week since prior core biopsy No prior surgery affecting absorption No concurrent major surgery Recovered from prior therapy No prior vascular endothelial growth factor (VEGF) or an epidermal growth factor receptor (EGFR) directed therapy No prior erlotinib At least 30 days since prior investigational drugs More than 1 month since prior thrombolytic agents Concurrent warfarin allowed provided the following criteria are met: Patient is on a therapeutic stable dose of warfarin INR ≤ 3 No active bleeding or pathological condition that would confer a high risk of bleeding (e.g., tumor invading adjacent organs or major blood vessels or varices that are likely to bleed) No other concurrent investigational agents No other concurrent anticancer therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gini Fleming
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

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