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

Western Regional Medical Center

Status and phase: Terminated; Phase 2

Conditions: Ovarian Carcinoma; Fallopian Tube Carcinoma; Peritoneal Carcinoma

Treatments: Drug: Bevacizumab; Drug: Carboplatin; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01936974

13-27

Details and patient eligibility

About

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

Full 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

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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7 participants in 2 patient groups

Platinum, Gemcitabine and Bevacizumab

Experimental group

Description:

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

Treatment:

Drug: Oxaliplatin

Drug: Cisplatin

Drug: Gemcitabine

Drug: Carboplatin

Drug: Bevacizumab

Gemcitabine and Bevacizumab

Active Comparator group

Description:

Gemcitabine on days 1 and 8 Bevacizumab on day 1

Treatment:

Drug: Gemcitabine

Drug: Bevacizumab