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Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer

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ClinicalTrials.gov Identifier: NCT00005837
Recruitment Status : Completed
First Posted : May 5, 2003
Last Update Posted : June 21, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

June 2, 2000
May 5, 2003
June 21, 2013
February 2000
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Complete list of historical versions of study NCT00005837 on ClinicalTrials.gov Archive Site
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Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer
Phase II Evaluation of Oxaliplatin in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix

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 oxaliplatin in treating patients who have recurrent or refractory cervical cancer.

OBJECTIVES: I. Determine the antitumor activity of oxaliplatin by measuring response rate in patients with recurrent or refractory squamous cell carcinoma of the cervix who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of this drug in this patient population.

OUTLINE: Patients receive oxaliplatin IV over 2 hours. Treatment continues every 21 days for a maximum of 9 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 12-14 months.

Interventional
Phase 2
Primary Purpose: Treatment
Cervical Cancer
Drug: oxaliplatin
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Fracasso PM, Blessing JA, Wolf J, Rocereto TF, Berek JS, Waggoner S. Phase II evaluation of oxaliplatin in previously treated squamous cell carcinoma of the cervix: a gynecologic oncology group study. Gynecol Oncol. 2003 Jul;90(1):177-80.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2004
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DISEASE CHARACTERISTICS: Histologically confirmed refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapeutic measures and considered incurable Bidimensionally measurable disease Must not be eligible for a higher priority GOG protocol No known brain metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine normal Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception No evidence of preexisting peripheral sensory neuropathy greater than CTC grade 1, including residual neuropathy attributed to prior chemotherapy and other chronic conditions (e.g., diabetes, venous stasis, and carpal tunnel syndrome) No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy No other uncontrolled concurrent illness (e.g., ongoing or active infection) No other malignancy within the past 5 years except nonmelanoma skin cancer and no other prior malignancy whose prior cancer treatment contraindicates this protocol therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors (CSFs) during first course of therapy At least 24 hours since prior CSFs during subsequent courses of therapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior oxaliplatin No more than 1 prior chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and recovered Other: At least 3 weeks since prior anticancer therapy and recovered No other concurrent investigational agents No concurrent antiretroviral therapy (HAART)

Sexes Eligible for Study: Female
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00005837
CDR0000067852
GOG-127P
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Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Paula M. Fracasso, MD, PhD Washington University Siteman Cancer Center
National Cancer Institute (NCI)
July 2004

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