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Trial: NCT00003369 [RDF]

Label NCT00003369
Slug nct00003369
Trialid NCT00003369
Lookup name NCT00003369
Provenance http://clinicaltrials.gov/show/NCT00003369?displayxml=true
Lastchanged date
Firstreceived results date
Firstreceived date
Id info nct id NCT00003369
Overall status Completed
Id info secondary id SWOG-S9717
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 56
Number of arms 1
Is section 801
Is fda regulated
Brief title S9717 Tirapazamine Plus Cisplatin in Treating Patients With Metastatic, Recurrent, or Refractory Cervical Cancer
Acronym
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 https://clinicaltrials.gov/show/NCT00003369
Study design
Source Southwest Oncology Group
Primary completion date October 2003
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on August 24, 2018
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 None
Intervention browse None
Responsible party None
Overall contact None
Overall contact backup None
Sponsor group None
Oversight info None
Eligibility None
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 9216f3c7eaa81b14055bebd6c5bf3dfb, PMID:16445649
Arm groups tirapazamine/cisplatin (Arm Group)
Location countries United States
Interventions cisplatin (Intervention), tirapazamine (Intervention)
Secondary outcomes None
References None
Primary outcomes 21dce9e794a403f0c0c181ba7b493139
Removed countries None
Overall officials None