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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.

Sponsors and Collaborators: Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00057863
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Drug: oxaliplatin
Drug: paclitaxel
Phase II

MedlinePlus related topics:   Cancer    Cervical Cancer   

Drug Information available for:   Paclitaxel    Oxaliplatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Study Of Oxaliplatin In Combination With Paclitaxel In Patients With Locally Recurrent Or Metastatic Cervical Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall objective response rate (complete and partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:   46
Study Start Date:   February 2003
Estimated Primary Completion Date:   June 2004 (Final data collection date for primary outcome measure)

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057863

Locations
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center    
      Farmington, Connecticut, United States, 06360-2875
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine    
      Bronx, New York, United States, 10461
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center    
      New York, New York, United States, 10032
Mount Sinai School of Medicine    
      New York, New York, United States, 10029
New York Weill Cornell Cancer Center at Cornell University    
      New York, New York, United States, 10021
NYU Cancer Institute at New York University Medical Center    
      New York, New York, United States, 10016
Australia, New South Wales
Sydney Cancer Centre at Royal Prince Alfred Hospital    
      Sydney, New South Wales, Australia, 2050

Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)

Investigators
Study Chair:     Dennis Y. Kuo, MD     Albert Einstein College of Medicine of Yeshiva University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000277249, AECM-0902492, NCI-5840
First Received:   April 7, 2003
Last Updated:   September 17, 2008
ClinicalTrials.gov Identifier:   NCT00057863
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent cervical cancer  
stage IVA cervical cancer  
stage IVB cervical cancer  
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
cervical adenocarcinoma

Study placed in the following topic categories:
Squamous cell carcinoma
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Recurrence
Carcinoma
Epidermoid carcinoma
Uterine Cervical Neoplasms
Genital Diseases, Female
Oxaliplatin
Uterine Cervical Diseases
Paclitaxel
Carcinoma, squamous cell
Uterine Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Carcinoma, Adenosquamous

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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