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

Phase 2

Terminated

• Conditions: Ovarian Carcinoma; Fallopian Tube Carcinoma; Peritoneal Carcinoma
• Interventions: Drug: Gemcitabine; Drug: Bevacizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Oxaliplatin

• Registration Number: NCT01936974
• Lead Sponsor: Western Regional Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-03
• Study First Posted: 2013-09-06
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2017-09-27
• Results First Submitted QC: 2017-09-27
• Results First Posted: 2017-10-25
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platinum, Gemcitabine and Bevacizumab	Gemcitabine	Platinum: 1. Carboplatin\* on day 1 \*If a patient is allergic to carboplatin, then give 2. Cisplatin\*\* on day 1 \*\*If a patient is allergic to cisplatin and carboplatin, then give 3. Oxaliplatin on day 1 Gemcitabine on day 1 only Bevacizumab on day 1
Platinum, Gemcitabine and Bevacizumab	Bevacizumab	Platinum: 1. Carboplatin\* on day 1 \*If a patient is allergic to carboplatin, then give 2. Cisplatin\*\* on day 1 \*\*If a patient is allergic to cisplatin and carboplatin, then give 3. Oxaliplatin on day 1 Gemcitabine on day 1 only Bevacizumab on day 1
Platinum, Gemcitabine and Bevacizumab	Carboplatin	Platinum: 1. Carboplatin\* on day 1 \*If a patient is allergic to carboplatin, then give 2. Cisplatin\*\* on day 1 \*\*If a patient is allergic to cisplatin and carboplatin, then give 3. Oxaliplatin on day 1 Gemcitabine on day 1 only Bevacizumab on day 1
Platinum, Gemcitabine and Bevacizumab	Cisplatin	Platinum: 1. Carboplatin\* on day 1 \*If a patient is allergic to carboplatin, then give 2. Cisplatin\*\* on day 1 \*\*If a patient is allergic to cisplatin and carboplatin, then give 3. Oxaliplatin on day 1 Gemcitabine on day 1 only Bevacizumab on day 1
Platinum, Gemcitabine and Bevacizumab	Oxaliplatin	Platinum: 1. Carboplatin\* on day 1 \*If a patient is allergic to carboplatin, then give 2. Cisplatin\*\* on day 1 \*\*If a patient is allergic to cisplatin and carboplatin, then give 3. Oxaliplatin on day 1 Gemcitabine on day 1 only Bevacizumab on day 1
Gemcitabine and Bevacizumab	Gemcitabine	Gemcitabine on days 1 and 8 Bevacizumab on day 1
Gemcitabine and Bevacizumab	Bevacizumab	Gemcitabine on days 1 and 8 Bevacizumab on day 1

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	One Year	Evaluate progression-free survival between the two regimens.

Trial Locations

Locations (1)

Western Regional Medical Center; 🇺🇸 Goodyear, Arizona, United States