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

NCT ID: NCT01936974

Last Updated: 2018-02-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-08-31

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

Conditions

Ovarian Carcinoma; Fallopian Tube Carcinoma; Peritoneal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Platinum, Gemcitabine and 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

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Patient to receive gemzar

Bevacizumab

Intervention Type: DRUG

Patient to receive avastin

Carboplatin

Intervention Type: DRUG

Patient to receive carboplatin

Cisplatin

Intervention Type: DRUG

Patient to receive cisplatin

Oxaliplatin

Intervention Type: DRUG

Patient to receive Oxaliplatin

Gemcitabine and Bevacizumab

Gemcitabine on days 1 and 8

Bevacizumab on day 1

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: DRUG

Patient to receive gemzar

Bevacizumab

Intervention Type: DRUG

Patient to receive avastin

Interventions

Gemcitabine

Patient to receive gemzar

Intervention Type: DRUG

Bevacizumab

Patient to receive avastin

Intervention Type: DRUG

Carboplatin

Patient to receive carboplatin

Intervention Type: DRUG

Cisplatin

Patient to receive cisplatin

Intervention Type: DRUG

Oxaliplatin

Patient to receive Oxaliplatin

Intervention Type: DRUG

Other Intervention Names

Gemzar; Avastin; Paraplatin; Platinol; Eloxatin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Western Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordan Waypa, FNP

Role: STUDY_DIRECTOR

Western Regional Medical Center

Locations

Western Regional Medical Center

Goodyear, Arizona, United States

Countries

United States

Other Identifiers

13-27

Identifier Type: -

Identifier Source: org_study_id