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A Phase II Trial of Bevacizumab (NSC# 704865) and OSI-774 (NSC# 718781) In Recurrent Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

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Trial Information

A Phase II Trial of Bevacizumab (NSC# 704865) and OSI-774 (NSC# 718781) In Recurrent Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Gini Fleming

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02660

NCT ID:

NCT00126542

Start Date:

April 2005

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location

University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470