- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00126542
Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (bevacizumab, erlotinib hydrochloride)
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.
|
Correlative studies
Given IV
Other Names:
Given orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate of patients treated with the combination of bevacizumab and OSI-774
Time Frame: Up to 5 years
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Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: Time from treatment commencement to disease progression or death, whichever comes first, assessed up to 5 years
|
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).
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Time from treatment commencement to disease progression or death, whichever comes first, assessed up to 5 years
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Median progression-free survival
Time Frame: From start of treatment to time of progression, assessed up to 5 years
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Overall survival rates and median overall survival times and their associated 90% confidence intervals will be determined by the same methods.
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From start of treatment to time of progression, assessed up to 5 years
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Overall survival
Time Frame: Up to 5 years
|
Overall survival rates and median overall survival times and their associated 90% confidence intervals will be determined by the same methods.
|
Up to 5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gini Fleming, University of Chicago
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Genital Neoplasms, Female
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Abdominal Neoplasms
- Ovarian Neoplasms
- Recurrence
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Carcinoma, Ovarian Epithelial
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Antibodies
- Erlotinib Hydrochloride
- Immunoglobulins
- Bevacizumab
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
Other Study ID Numbers
- NCI-2012-02660 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- N01CM62201 (U.S. NIH Grant/Contract)
- N01CM62203 (U.S. NIH Grant/Contract)
- P30CA014599 (U.S. NIH Grant/Contract)
- N01CM62209 (U.S. NIH Grant/Contract)
- UCCRC-13576A
- NCI-6759
- CDR0000434820
- 13576A (Other Identifier: University of Chicago)
- 6759 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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