(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma (PGA)

Platinum-Gemcitabine-Avastin (PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma

To evaluate progression-free survival with two chemotherapy regimens on platinum-resistant/refractory ovarian and peritoneal carcinoma

Study Overview

• Status: Terminated
• Conditions: Fallopian Tube Carcinoma; Peritoneal Carcinoma; Ovarian Carcinoma
• Intervention / Treatment: Drug: Gemcitabine; Drug: Bevacizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Oxaliplatin

Detailed Description

This study will evaluate progression-free survival (PFS)for the regimen of gemcitabine and bevacizumab with or without a platinum agent on platinum-resistant/refractory ovarian and peritoneal carcinoma

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Western Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Patients ≥ 18 years of age with histologically confirmed, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer

2. Disease progression during or within 6 months of previous platinum-based chemotherapy including the following 4 categories:

   1. Primary platinum-refractory: Previously untreated patients who do not achieve at least a partial response to platinum-based chemotherapy
   2. Primary platinum-resistant: Previously untreated patients who have achieved at least a partial response to platinum-based chemotherapy but experience a relapse within a period of 6 months of its conclusion
   3. Secondary platinum-refractory: Previously treated patients have a relapse 6 months after the conclusion of chemotherapy, but fail to achieve at least a partial response
   4. Secondary platinum-resistant: Previously treated patients have a relapse 6 months after the conclusion of chemotherapy, achieve at least a partial response with platinum-based therapy as 2nd-line therapy, but experience relapse within 6 months
3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2 and a life expectancy >3 months.
4. Absolute neutrophil count > 1500 mm^3, platelet count ≥ 100×10^9 L, hemoglobin ≥ 8.5 g/dL
5. Serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
6. No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator
7. At least three (3) weeks from prior chemotherapy

Exclusion Criteria:

1. Inadequate renal function with a calculated creatinine clearance less than 51 mL/min
2. Uncontrolled cardiac disease, congestive heart failure, angina, or hypertension
3. Myocardial infarction or unstable angina within 2 months of treatment
4. Known human immunodeficiency virus (HIV) infection or chronic active Hepatitis B or C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol)
5. Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks, pulmonary embolism within the past 6 months
6. Bleeding diathesis or significant coagulopathy
7. Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug
8. Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug
9. History of fistula, GI perforation, or intrabdominal abscess
10. Serious non-healing wound, ulcer, or bone fracture
11. clinical signs or symptoms of GI obstruction and/or requirement for parenteral hydration or nutrition
12. Known CNS disease except for treated brain metastasis
13. Known platinum drug allergy
14. Prior treatment with Platinum + Gemcitabine + Avastin, Gemcitabine + Avastin or Gemcitabine alone
15. Prior treatment with more than three (3) lines of chemotherapy including adjuvant chemotherapy
16. Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug
17. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
18. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platinum, Gemcitabine and Bevacizumab; Platinum: Carboplatin* on day 1*If a patient is allergic to carboplatin, then give; Cisplatin** on day 1**If a patient is allergic to cisplatin and carboplatin, then give; Oxaliplatin on day 1 Gemcitabine on day 1 only Bevacizumab on day 1	Drug: Gemcitabine; Patient to receive gemzar; Other Names: Gemzar; Drug: Bevacizumab; Patient to receive avastin; Other Names: Avastin; Drug: Carboplatin; Patient to receive carboplatin; Other Names: Paraplatin; Drug: Cisplatin; Patient to receive cisplatin; Other Names: Platinol; Drug: Oxaliplatin; Patient to receive Oxaliplatin; Other Names: Eloxatin
Active Comparator: Gemcitabine and Bevacizumab; Gemcitabine on days 1 and 8 Bevacizumab on day 1	Drug: Gemcitabine; Patient to receive gemzar; Other Names: Gemzar; Drug: Bevacizumab; Patient to receive avastin; Other Names: Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival	Evaluate progression-free survival between the two regimens.	One Year

Collaborators and Investigators

• Sponsor: Western Regional Medical Center
• Investigators: Study Director: Jordan Waypa, FNP, Western Regional Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 3, 2013
• First Submitted That Met QC Criteria: September 3, 2013
• First Posted (Estimate): September 6, 2013

Study Record Updates

• Last Update Posted (Actual): February 20, 2018
• Last Update Submitted That Met QC Criteria: January 22, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Gemcitabine; Carboplatin; Oxaliplatin; Bevacizumab
• Other Study ID Numbers: 13-27