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Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in theTreatment of Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer


Phase 2
21 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

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Trial Information

Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in theTreatment of Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer


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conditions that have occurred in the last 6 months but are no longer active at the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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine if patients have lower rates of hypersensitivity reactions compared to those treated with standard infusion carboplatin.

Outcome Description:

The primary objective of this study is to perform a randomized study to determine whether patients treated for relapsed ovary, fallopian and primary peritoneal with extended infusion carboplatin.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Roisin O'Cearbhaill, MD BCh

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

10-184

NCT ID:

NCT01248962

Start Date:

November 2010

Completion Date:

November 2013

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • BEVACIZUMAB (AVASTIN)
  • CARBOPLATIN
  • DEXAMETHASONE
  • GEMCITABINE
  • LIPODOX(LIPOSOMAL DOXORUBICIN)
  • MONTELUKAST (SINGULAR)
  • TAXOL (PACLITAXEL
  • Fallopian Tubes
  • 10-184
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021