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

Stopped early · Phase 2

Conditions studied: Ovarian Carcinoma, Fallopian Tube Carcinoma, Peritoneal Carcinoma

In brief

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

Key facts

Study ID

NCT01936974

Run by

Western Regional Medical Center

People needed

7

Starts

2013-09-01

Expected to finish

2015-08-01

Last updated by the study team

2018-02-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients ≥ 18 years of age with histologically confirmed, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
• Disease progression during or within 6 months of previous platinum-based chemotherapy including the following 4 categories:
• Primary platinum-refractory: Previously untreated patients who do not achieve at least a partial response to platinum-based chemotherapy
• 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
• 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
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2 and a life expectancy >3 months.
• Absolute neutrophil count > 1500 mm\^3, platelet count ≥ 100×10\^9 L, hemoglobin ≥ 8.5 g/dL
• 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
• No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator
• At least three (3) weeks from prior chemotherapy

You may not qualify if…

• Inadequate renal function with a calculated creatinine clearance less than 51 mL/min
• Uncontrolled cardiac disease, congestive heart failure, angina, or hypertension
• Myocardial infarction or unstable angina within 2 months of treatment
• 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)
• Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks, pulmonary embolism within the past 6 months
• Bleeding diathesis or significant coagulopathy
• Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug
• Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug
• History of fistula, GI perforation, or intrabdominal abscess
• Serious non-healing wound, ulcer, or bone fracture
• clinical signs or symptoms of GI obstruction and/or requirement for parenteral hydration or nutrition
• Known CNS disease except for treated brain metastasis
• Known platinum drug allergy
• Prior treatment with Platinum + Gemcitabine + Avastin, Gemcitabine + Avastin or Gemcitabine alone
• Prior treatment with more than three (3) lines of chemotherapy including adjuvant chemotherapy
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug
• Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
• Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements

Where it is running

• Western Regional Medical Center — Goodyear, Arizona, United States

Full record on ClinicalTrials.gov

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