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Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer
This study is ongoing, but not recruiting participants.
Study NCT00057863   Information provided by National Cancer Institute (NCI)
First Received: April 7, 2003   Last Updated: September 17, 2008   History of Changes

April 7, 2003
September 17, 2008
February 2003
June 2004   (final data collection date for primary outcome measure)
Overall objective response rate (complete and partial response) [ Designated as safety issue: No ]
  • Objective response rate
  • Toxic effects
  • Recovery
Complete list of historical versions of study NCT00057863 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival
  • Overall survival
 
Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer
A Phase II Study Of Oxaliplatin In Combination With Paclitaxel In Patients With Locally Recurrent Or Metastatic Cervical Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with paclitaxel in treating patients who have locally recurrent or metastatic cervical cancer.

OBJECTIVES:

  • Determine the objective response rate of patients with locally recurrent or metastatic cervical cancer treated with oxaliplatin and paclitaxel.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the recovery from toxic effects in patients treated with this regimen.

OUTLINE: Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed ever 3 months.

PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 9-23 months.

Phase II
Interventional
Treatment, Open Label
Cervical Cancer
  • Drug: oxaliplatin
  • Drug: paclitaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
46
 
June 2004   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed cervical cancer of 1 of the following subtypes:

    • Squamous cell
    • Adenosquamous cell
    • Adenocarcinoma
  • Metastatic disease to organs or lymph nodes outside the pelvis OR
  • Locally recurrent disease in the pelvis after definitive therapy (surgery or radiotherapy) with at least 50% increase in size by sequential imaging studies
  • Measurable disease

    • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 2 months

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal

Renal

  • Creatinine normal

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to oxaliplatin, cisplatin, carboplatin, paclitaxel, or docetaxel
  • No concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Prior chemotherapy administered with radiotherapy as primary, definitive therapy allowed
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • See Chemotherapy
  • More than 4 weeks since prior radiotherapy and recovered

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery

Other

  • No prior cytotoxic agents for advanced or recurrent disease
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or commercial agents or therapies for the malignancy
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00057863
 
CDR0000277249, AECM-0902492, NCI-5840
Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
Study Chair: Dennis Y. Kuo, MD Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
July 2008

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