Clinical Trials Logo
  1. Home
  2. Stage IB Cervical Cancer
  3. NCT00107445

EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical, Endometrial, or Ovarian Epithelial Cancer

Primary Peritoneal Cavity Cancer Clinical Trial

Official title:
Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer

Clinical Trial Summary

This phase II trial is studying how well EF5 works in finding oxygen in tumor cells of patients who are undergoing surgery or biopsy for cervical, endometrial, or ovarian epithelial cancer. Diagnostic procedures using the drug EF5 to find oxygen in tumor cells may help in planning cancer treatment

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Correlate the level of EF5 binding with pre-treatment hemoglobin level and tumor grade and stage in patients undergoing surgery or biopsy for cervical, endometrial, or ovarian epithelial cancer.

SECONDARY OBJECTIVES:

I. Correlate pre-treatment tumor hypoxia (as measured by EF5 binding) with time to progression and time to recurrence in these patients.

II. Correlate EF5 binding with CD-31 expression (tumor vasculature), Ki-67 expression (cellular proliferation), and erythropoietin signaling in these patients.

OUTLINE:

Patients receive EF5 IV over 1-2½ hours on day 1. Approximately 1-2 days later, patients undergo tumor resection or biopsy. Patients' tumor tissue samples undergo immunohistochemistry and flow cytometry to detect EF5 binding levels. Patients' blood is drawn immediately before and 30-60 minutes and 1-2 days after receiving EF5 to measure systemic EF5 binding levels.

Patients are followed at 30-45 days after administration of EF5 and then every 3-6 months thereafter. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

  • Carcinoma
  • Endometrial Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Primary Peritoneal Cavity Cancer
  • Stage I Endometrial Carcinoma
  • Stage I Ovarian Epithelial Cancer
  • Stage IA Cervical Cancer
  • Stage IB Cervical Cancer
  • Stage II Endometrial Carcinoma
  • Stage II Ovarian Epithelial Cancer
  • Stage IIA Cervical Cancer
  • Stage IIB Cervical Cancer
  • Stage III Cervical Cancer
  • Stage III Endometrial Carcinoma
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Endometrial Carcinoma
  • Stage IV Ovarian Epithelial Cancer
  • Stage IVA Cervical Cancer
  • Stage IVB Cervical Cancer
  • Uterine Cervical Neoplasms
Clinical Trial Details
NCT number NCT00107445
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date February 2005
View Details
See also
  Status Clinical Trial Phase
Terminated NCT00903396 - Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer Phase 2
Completed NCT00263822 - Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer Phase 3
Terminated NCT00091195 - Depsipeptide (Romidepsin) in Treating Patients With Recurrent Ovarian Epithelial or Peritoneal Cavity Cancer Phase 2
Completed NCT00075712 - Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Phase 2/Phase 3
Completed NCT00012090 - Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary, Fallopian Tube, or Peritoneum Phase 2
Completed NCT00003967 - Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer Phase 1
Completed NCT00019552 - Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer Phase 2
Completed NCT00003636 - Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer Phase 3
Active, not recruiting NCT00003160 - Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum Phase 2
Completed NCT00002538 - Laparoscopic Staging in Patients With Ovarian, Fallopian Tube, or Other Primary Abdominal Cancers Phase 2
Completed NCT00002600 - Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer Phase 1
Active, not recruiting NCT00838656 - Two Different Schedules of Carboplatin, Paclitaxel, Gemcitabine, and Surgery in Treating Patients With Newly Diagnosed Stage IIIC or Stage IV Primary Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Phase 2
Completed NCT00093496 - Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer Phase 2
Completed NCT00398138 - Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma Phase 1
Completed NCT00132067 - Vorinostat in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cavity Cancer Phase 2
Completed NCT00049556 - Gefitinib in Treating Patients With Cervical Cancer Phase 2
Terminated NCT00028782 - EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer N/A
Completed NCT00006942 - Bryostatin 1 and Cisplatin in Treating Patients With Advanced Recurrent or Residual Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Phase 2
Completed NCT00003998 - Carboplatin Plus Paclitaxel or Docetaxel in Treating Patients With Ovarian Epithelial Cancer Phase 3
Completed NCT00003670 - Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Metastatic Refractory Ovarian Cancer or Primary Peritoneal Cancer Phase 2