Trial record 18 of 3199 for:    Open Studies | "Carcinoma"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 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: NA
Last verified: September 2013
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
    Evaluate progression-free survival between the two regimens.


Estimated Enrollment: 88
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years and older
Genders 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 mm3, platelet count ≥ 100×109 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 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. Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug
  15. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
  16. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936974

Contacts
Contact: Marci Pierog, RN-BC, OCN 623-207-3818 marci.pierog@ctca-hope.com
Contact: Brenda Noggy, RN BSN 623-207-3541 brenda.noggy@ctca-hope.com

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

No publications provided

Responsible Party: Jiaxin Niu, MD, PhD, Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01936974     History of Changes
Other Study ID Numbers: 13-27
Study First Received: September 3, 2013
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Fallopian Tube Neoplasms
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
Gemcitabine
Oxaliplatin
Bevacizumab
Cisplatin
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014