Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
Condition: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
MeSH terms: Fallopian Tube Neoplasms; Peritoneal Neoplasms
Intervention: carboplatin; carboplatin
Intervention description: Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion.; Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion.
Intervention MeSH terms: Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: BEVACIZUMAB (AVASTIN); CARBOPLATIN; DEXAMETHASONE; GEMCITABINE; LIPODOX(LIPOSOMAL DOXORUBICIN); MONTELUKAST (SINGULAR); TAXOL (PACLITAXEL; Fallopian Tubes; 10-184

Summary:

      Patients who have this kind of cancer are often treated with several drugs. Carboplatin is
      one that seems to work for many treatment cycles. Even though it may work against the cancer,
      the patient can become allergic to it. If that happens, they would have to stop taking the
      drug. The standard way to give carboplatin is by vein over 30 minutes. Some people have been
      given carboplatin over 3 hours rather than 30 minutes and had fewer allergies than expected.

      The purpose of this study is to:

      Find out if giving carboplatin over three hours can prevent the allergy.

      See if medicine given before the carboplatin can help reduce the risk of allergic reactions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  MSKCC Histologically confirmed ovarian, fallopian tube or primary peritoneal
             carcinoma.

          -  Patient has received at least one prior platinum-containing (cisplatin or carboplatin)
             regimen

          -  Age ≥ 21 years old

          -  Karnofsky Performance Status (KPS) > or = to 70%

          -  Adequate hematologic, hepatic and renal function as defined below:

          -  Hemoglobin ≥ 7.0 g/dl

          -  Absolute neutrophil count ≥ 1,000/mm3

          -  Platelet count ≥ 100,000/mm3

          -  Serum creatinine ≤ 1.5 x the upper limit of normal or calculated creatinine clearance
             ≥ 60 mL/min

        Exclusion Criteria:

          -  Prior carboplatin or cisplatin hypersensitivity reaction

          -  Uncontrolled intercurrent illness including infection, congestive heart failure,
             myocardial infarction, transient ischemic attack or stroke within 6 months. Any such
             conditions that have occurred in the last 6 months but are no longer active at the
             time of registration are not considered exclusionary.

          -  Patients receiving other investigational agents

          -  Patients with HIV disease will be permitted, only if they are on effective
             antiretroviral therapy, have a CD4 count greater than 400, and have had no
             opportunistic infections within the past 6 months

          -  Pregnant or lactating women

          -  Life expectancy of less than 12 weeks