Full Text View
Tabular View
No Study Results Posted
Related Studies
TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
This study is ongoing, but not recruiting participants.
Study NCT00022347   Information provided by National Cancer Institute (NCI)
First Received: August 10, 2001   Last Updated: October 29, 2009   History of Changes

August 10, 2001
October 29, 2009
May 2001
 
  • Objective response rate [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Duration of objective response [ Designated as safety issue: No ]
  • Time to tumor progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Objective response rate
  • Safety
  • Duration of objective response
  • Time to tumor progression
  • Overall survival
Complete list of historical versions of study NCT00022347 on ClinicalTrials.gov Archive Site
 
 
 
TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
A Phase II Study of TLK 286 in Platinum Resistant Advanced Epithelial Ovarian Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of TLK286 in treating patients who have advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

OBJECTIVES: I. Determine the objective response rate and disease stabilization rate in patients with platinum-resistant advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer treated with TLK286. II. Determine the safety of this regimen in these patients. III. Determine the duration of objective response, time to tumor progression, and overall survival in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive TLK286 IV over 30 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for 1 year and then every 12 weeks thereafter.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 12 months.

Phase II
Interventional
Treatment
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
Drug: canfosfamide hydrochloride
 
Kavanagh JJ, Gershenson DM, Choi H, Lewis L, Patel K, Brown GL, Garcia A, Spriggs DR. Multi-institutional phase 2 study of TLK286 (TELCYTA, a glutathione S-transferase P1-1 activated glutathione analog prodrug) in patients with platinum and paclitaxel refractory or resistant ovarian cancer. Int J Gynecol Cancer. 2005 Jul-Aug;15(4):593-600.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer Serous papillary Endometrioid Mucinous Clear cell Poorly differentiated adenocarcinomas Mixture of any of the above histologies No sarcomatous, stromal, or germ cell elements Measurable disease by radiological imaging with progression in the past 3 months or no response to prior therapy The following are not considered measurable: Pleural effusions Ascites Osseous metastases CA-125 tumor markers Lesions in previously irradiated areas Platinum resistant or refractory Less than 6 month treatment-free interval after platinum-containing regimen OR Progression during platinum-based therapy No leptomeningeal or carcinomatous meningitis Known CNS metastases allowed if patient is previously treated, neurologically stable, has no evidence of active disease by CT or MRI, and has no requirement for therapy with oral or IV steroids or anticonvulsants

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2.5 mg/dL ALT and AST no greater than 3.0 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min No gross hematuria Cardiovascular: No uncontrolled cardiac arrhythmia No myocardial infarction within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 6 months after study No unstable medical conditions No severe concurrent disease or infection that would preclude study No intestinal obstruction interfering with nutrition No psychiatric disorders that would preclude study No other prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered At least 2 weeks since prior prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) No concurrent immunotherapy No concurrent biological response modifiers Chemotherapy: See Disease Characteristics At least 1 but no more than 3 prior chemotherapy regimens (platinum-containing regimens count as 1 regimen) At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy or radiopharmaceuticals and recovered No prior radiotherapy to whole pelvis No concurrent radiotherapy including palliative radiotherapy (except local radiotherapy for pain or solitary brain metastasis if not progressing systemically) Surgery: At least 4 weeks since prior major surgery and recovered Other: At least 30 days since prior investigational drugs No other concurrent investigational agents

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00022347
 
CDR0000068807, MSKCC-01059, TLK-286.2003, NCI-G01-1998
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: David R. Spriggs, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP