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

Ovarian Carcinoma Clinical Trial

— PGA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01936974
• Other study ID #: 13-27
• Status: Terminated
• Phase: Phase 2
• First received: September 3, 2013
• Last updated: January 22, 2018
• Start date: September 2013
• Est. completion date: August 2015

Study information

• Verified date: January 2018
• Source: Western Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Fallopian Tube Carcinoma
• Fallopian Tube Neoplasms
• Ovarian Carcinoma
• Ovarian Neoplasms
• Peritoneal Carcinoma

Intervention

Drug:
• Gemcitabine
Patient to receive gemzar
• Bevacizumab
Patient to receive avastin
• Carboplatin
Patient to receive carboplatin
• Cisplatin
Patient to receive cisplatin
• Oxaliplatin
Patient to receive Oxaliplatin

Locations

Country	Name	City	State
United States	Western Regional Medical Center	Goodyear	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Western Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	Evaluate progression-free survival between the two regimens.	One Year