We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    PGA niu
Previous Study | Return to List | Next Study

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

This study has been terminated.
(PI Decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01936974
First Posted: September 6, 2013
Last Update Posted: December 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Western Regional Medical Center
  Purpose
To evaluate progression-free survival with two chemotherapy regimens on platinum-resistant/refractory ovarian and peritoneal carcinoma

Condition Intervention Phase
Ovarian Carcinoma Fallopian Tube Carcinoma Peritoneal Carcinoma Drug: Gemcitabine Drug: Bevacizumab Drug: Carboplatin Drug: Cisplatin Drug: Oxaliplatin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Platinum-Gemcitabine-Avastin (PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by Western Regional Medical Center:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: One Year ]
    Evaluate progression-free survival between the two regimens.


Enrollment: 7
Study Start Date: September 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Active Comparator: Gemcitabine and Bevacizumab

Gemcitabine on days 1 and 8

Bevacizumab on day 1

Drug: Gemcitabine
Other Name: Gemzar
Drug: Bevacizumab
Other Name: Avastin

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936974


Locations
United States, Arizona
Western Regional Medical Center
Goodyear, Arizona, United States, 85338
Sponsors and Collaborators
Western Regional Medical Center
Investigators
Principal Investigator: Jiaxin Niu, MD, PhD Western Regional Medical Center
  More Information

Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01936974     History of Changes
Other Study ID Numbers: 13-27
First Submitted: September 3, 2013
First Posted: September 6, 2013
Results First Submitted: September 27, 2017
Results First Posted: October 25, 2017
Last Update Posted: December 5, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Paclitaxel
Gemcitabine
Oxaliplatin
Cisplatin
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites