Clinical Trials Logo
  1. Home
  2. Primary Peritoneal Cavity Cancer
  3. NCT00093496

Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer

Primary Peritoneal Cavity Cancer Clinical Trial

Official title:
A Phase II Trial Of Gemcitabine in Combination With 17-Allylaminogeldamycin (17-AAG) In Advanced Epithelial Ovarian And Primary Peritoneal Carcinoma

Clinical Trial Summary

Phase II trial to study the effectiveness of gemcitabine hydrochloride and tanespimycin in treating patients who have recurrent advanced ovarian epithelial or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing or die.

Clinical Trial Description

OBJECTIVES:

I. Determine the response rate, time to progression, and survival of patients with recurrent advanced ovarian epithelial or primary peritoneal cavity cancer treated with gemcitabine hydrochloride and 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) (tanespimycin).

II. Determine the toxicity of this regimen in these patients. III. Correlate the effect of 17-AAG alone on chaperone and client proteins in tumor samples and peripheral blood mononuclear cells with response, time to progression, and survival of these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to gemcitabine hydrochloride therapy (gemcitabine hydrochloride-naive/no prior exposure to gemcitabine hydrochloride vs gemcitabine hydrochloride-resistant/prior exposure to gemcitabine hydrochloride as a single agent with disease progression while on treatment). Patients receive tanespimycin intravenously (IV) over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00093496
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date October 2007
Completion date March 2012
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 NCT00003636 - Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer Phase 3
Completed NCT00019552 - Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer Phase 2
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 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 NCT00003670 - Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Metastatic Refractory Ovarian Cancer or Primary Peritoneal Cancer Phase 2
Completed NCT00003998 - Carboplatin Plus Paclitaxel or Docetaxel in Treating Patients With Ovarian Epithelial Cancer Phase 3
Completed NCT00003345 - Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer Phase 2