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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02660 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| UCCRC-13576A | |||
| NCI-6759 | |||
| CDR0000434820 | |||
| 13576A | Other Identifier | University of Chicago | |
| 6759 | Other Identifier | CTEP | |
| N01CM62209 | U.S. NIH Grant/Contract | View source | |
| P30CA014599 | U.S. NIH Grant/Contract | View source | |
| N01CM62201 | U.S. NIH Grant/Contract | View source | |
| N01CM62203 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (bevacizumab, erlotinib hydrochloride) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of patients treated with the combination of bevacizumab and OSI-774 | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Time from treatment commencement to disease progression or death, whichever comes first, assessed up to 5 years |
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Inclusion Criteria:
Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
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
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:
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:
No other concurrent investigational agents
No other concurrent anticancer therapy
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| Name | Affiliation | Role |
|---|---|---|
| Gini Fleming | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| erlotinib hydrochloride | Drug | Given orally |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| 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. | From start of treatment to time of progression, assessed up to 5 years |
| Overall survival | 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 |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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