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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Western Regional Medical Center
Sponsor:
Information provided by (Responsible Party):
Jiaxin Niu, Western Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01936974
First received: September 3, 2013
Last updated: January 19, 2015
Last verified: January 2015

September 3, 2013
January 19, 2015
September 2013
September 2015   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: One Year ] [ Designated as safety issue: No ]
Evaluate progression-free survival between the two regimens.
Same as current
Complete list of historical versions of study NCT01936974 on ClinicalTrials.gov Archive Site
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(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma
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
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Ovarian Carcinoma
  • Fallopian Tube Carcinoma
  • Peritoneal Carcinoma
  • Drug: Gemcitabine
    Other Name: Gemzar
  • Drug: Bevacizumab
    Other Name: Avastin
  • Drug: Carboplatin
    Other Name: Paraplatin
  • Drug: Cisplatin
    Other Name: Platinol
  • Drug: Oxaliplatin
    Other Name: Eloxatin
  • Experimental: 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

    Interventions:
    • Drug: Gemcitabine
    • Drug: Bevacizumab
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Oxaliplatin
  • Active Comparator: Gemcitabine and Bevacizumab

    Gemcitabine on days 1 and 8

    Bevacizumab on day 1

    Interventions:
    • Drug: Gemcitabine
    • Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
88
September 2016
September 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
No
Contact: Marci Pierog, RN-BC, OCN 623-207-3818 marci.pierog@ctca-hope.com
Contact: Lisa Blaydorn, RN, OCN, CRNI 623-207-3183 lisa.blaydorn@ctca-hope.com
United States
 
NCT01936974
13-27
No
Not Provided
Not Provided
Jiaxin Niu, Western Regional Medical Center
Western Regional Medical Center
Not Provided
Principal Investigator: Jiaxin Niu, MD, PhD Western Regional Medical Center
Western Regional Medical Center
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP