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Phase I Evaluation of Intravenous Carboplatin With Weekly Paclitaxel and Bevacizumab in Patients Undergoing Neoadjuvant Chemotherapy for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer


Phase 1
18 Years
90 Years
Open (Enrolling)
Female
Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

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Trial Information

Phase I Evaluation of Intravenous Carboplatin With Weekly Paclitaxel and Bevacizumab in Patients Undergoing Neoadjuvant Chemotherapy for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer


Phase I study proposed to evaluate:

- Tolerability of IV regimen carboplatin, paclitaxel and bevacizumab in the neoadjuvant
setting prior to surgery.

- Safety/Toxicity of IV regimen in this patient population

- Treatment is Carboplatin area under the concentration curve (AUC) 5, Bevacizumab
15mg/m2, and starting dose of paclitaxel of 60mg/m2 and will be escalated in intervals
of 10mg/m2 to a maximum dose of 80mg/m2.

- Patients will receive cycles 1-3 of carboplatin, bevacizumab, and paclitaxel and then
cycle 4 will be carboplatin and paclitaxel followed by surgical intervention within 6
weeks of cycle 4.

- Post surgical treatment per physician discretion


Inclusion Criteria:



- histology,cytologically diagnosed epithelial ovarian, primary peritoneal or fallopian
tube cancer

- FIGO stage III or IV disease

- GOG Performance Status 0,1,2

- No prior surgery for their malignancy

- Adequate bone marrow function

- Platelet count greater than or equal to 100,000

- Renal Function: Creatinine < 1.5 institutional upper limit normal

- Hepatic Function: Bilirubin less than 1.5 ULN

- Hepatic Function: SGOT and Alkaline Phosphate

- Neurologic Function: Neuropathy less than CTCAE grade 1

- Coagulation Functions: INR<1.5 and PTT ,1.2 times the upper limit of normal

- Measurable disease

Exclusion Criteria:

- Previous cancer related surgery

- Received prior chemotherapy, immunotherapy, radiotherapy, hormonal therapy or
biologic therapy for their ovarian, fallopian tube or primary peritoneal cancer.

- Borderline ovarian tumors, recurrent epithelial ovarian or primary peritoneal cancer
or non-epithelial ovarian are not eligible.

- Other cancers within 5 years (other than non-melanoma skin cancer)

- Acute Hepatitis or end stage liver disease

- History of prior gastrointestinal perforation

- Evidence of abdominal free air not explained by paracentesis

- Sign or symptoms of gastrointestinal obstruction

- Active bleeding or pathologic conditions that carry high risk of bleeding

- CNS disease

- Clinically Significant cardiovascular disease

- Known hypersensitivity to Chinese Hamster ovary cell products or other recombinant
human or humanized antibodies

- Clinically significant proteinuria.

- Hypertensive crises or hypertensive encephalopathy

- History of hemoptysis

- Any non-study related invasive procedure within 28days fo first date of bevacizumab

- GOG performance status 3 or 4

- Patients who are pregnant or nursing.

- Under the age of 18

- Received prior treatment of bevacizumab or any anti-VEGF drug

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerated Dose

Outcome Description:

To determine the maximum tolerated dose of carboplatin AUC5 administered Day 1 Cycles 1-4, weekly paclitaxel 60-80mg/m2 administered on Day 1, 8,and 15 for 3 weeks cycles 1-4, bevacizumab 15mg/kg administered Day 1 Cycles 1-3 prior to surgical intervention.

Outcome Time Frame:

3 patients per dose level with minmum of 4 weeks observation period

Safety Issue:

Yes

Principal Investigator

Ritu Salani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

OSU-09149

NCT ID:

NCT01219777

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
  • bevacizumab
  • paclitaxel
  • carboplatin
  • ovarian
  • cancer
  • fallopian tube
  • primary peritoneal
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Ohio State University Medical CenterColumbus, Ohio  43210