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Trial: NCT00003369 [RDF]

Label NCT00003369
Slug nct00003369
Trialid NCT00003369
Lookup name NCT00003369
Lastchanged date June 13, 2012
Firstreceived results date
Firstreceived date November 1, 1999
Id info nct id NCT00003369
Overall status Completed
Id info secondary id SWOG-S9717
Biospec retention
Required header link text Link to the current record.
Enrollment 56
Number of arms 1
Is section 801 Yes
Is fda regulated Yes
Brief title S9717 Tirapazamine Plus Cisplatin in Treating Patients With Metastatic, Recurrent, or Refractory Cervical Cancer
Official title Evaluation of Intravenously Administered Tirapazamine Plus Cisplatin in Cervical Cancer
Study type Interventional
Id info nct alias
Completion date July 2004
Verification date June 2012
Why stopped
Id info org study id CDR0000066358
Required header url
Study design Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Source Southwest Oncology Group
Primary completion date October 2003
Brief summary
Number of groups
Required header download date processed this data on September 08, 2016
Phase Phase 2
Start date August 1998
Has expanded access No
Biospec descr
Detailed description OBJECTIVES: I. Evaluate the survival of patients with metastatic or recurrent epithelial squamous or adenosquamous carcinoma of the cervix when treated with intravenous tirapazamine plus intravenous cisplatin. II. Evaluate the unconfirmed complete and partial response rates of these patients, as well as, the nature and degree of toxicity associated with this regimen in this patient population. OUTLINE: Patients receive tirapazamine intravenously over 2 hours and then, following a 1 hour rest, receive cisplatin intravenously over 1 hour. Courses are repeated every 21 days. Treatment continues for 6-10 courses in the absence of unacceptable toxic effects or disease progression. All patients are followed every 6 months for 2 years, then annually thereafter until death. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Condition browse a031c32a1774db2b7f584a647483220c
Intervention browse 900646fb9b7f0a09d9c42bed880eca0c
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group 4013476863ce520eb400b4a7f899b4fd
Oversight info United States: Federal Government (Oversight_info)
Eligibility a6e4175a2cdc8c3157e066ed58670c71
Keywords cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, recurrent cervical cancer, stage IV cervical cancer
Conditions Cervical Cancer
Locations 02ef181a1816c6c6294cf12e49654465, 071c8420ed775d08f0e6d787c23a9c65, 0858badcb962c83f1d3f69b0a5352a6f More →
Links None
Results references None
Arm groups tirapazamine/cisplatin (Arm Group)
Location countries United States
Interventions cisplatin (Intervention), tirapazamine (Intervention)
Secondary outcomes None
References None
Primary outcomes 799eb741251e794680684df62cfafaf2
Removed countries None
Overall officials 3a3bd1d2dd29195ba59ed1575d44e34f