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Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer



Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer

For Condition: cervical adenosquamous cell carcinoma,stage 4B cervical cancer,recurrent cervical cancer,stage 4A cervical cancer,cervical adenocarcinoma,cervical squamous cell carcinoma
Status: Recruiting
Sponsor(s): Cornell University Medical College , National Cancer Institute (NCI)
Synopsis: 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 locallyrecurrent or metastaticcervical cancer.
Details: 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. PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 9-23 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
Yi-ShinKuo,  Study Chair,  Cornell University Medical College

Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City,  New York,  10032
United States
Recruiting Dawn  Hershman 212-305-1945

University of Connecticut Cancer Center at University of Connecticut Health Center *Recruiting*
Farmington,  Connecticut,  06030
United States
Recruiting Carolyn  Runowicz 860-679-2609

Sydney Cancer Centre at Royal Prince Alfred Hospital *Recruiting*
Sydney,  New South Wales,  2050
Australia
Recruiting Anne  Hamilton 61-2-9515-5494

NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City,  New York,  10016
United States
Recruiting Stephanie  Blank 212-263-2668

Albert Einstein Clinical Cancer Center *Recruiting*
Bronx,  New York,  10461
United States
Recruiting Gary  Goldberg 718-430-2302

New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City,  New York,  10021
United States
Recruiting Yi-Shin  Kuo 212-746-4750

Mount Sinai School of Medicine *Recruiting*
New York City,  New York,  10029
United States
Recruiting Jamal  Rahaman 212-241-6500


Additional Information:
Study ID Numbers:
  CDR0000277249;  NCI-5840,NYWCCC-0902-492
Study Start Date: 
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057863

Other Cervical Adenosquamous Cell Carcinoma Studies:
1. Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

2. Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer

3. Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix

4. Comparison of Cisplatin Combined With Either Paclitaxel or Gemcitabine in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer

5. Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer

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