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	Treatment or Intervention	Phase
recurrent cervical cancer stage IVA cervical cancer stage IVB cervical cancer cervical adenosquamous cell carcinoma cervical squamous cell carcinoma cervical adenocarcinoma	Drug: oxaliplatin  Drug: paclitaxel  Procedure: chemotherapy	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Connecticut
      Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington,  Connecticut,  06030-1614,  United States; Recruiting
New York
      Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx,  New York,  10461,  United States; Recruiting
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting
      Mount Sinai School of Medicine, New York,  New York,  10029,  United States; Recruiting
      New York Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  United States; Recruiting
      NYU Cancer Institute at New York University Medical Center, New York,  New York,  10016,  United States; Recruiting
Australia, New South Wales
      Sydney Cancer Centre at Royal Prince Alfred Hospital, Sydney,  New South Wales,  2050,  Australia; Recruiting

Study chairs or principal investigators

Dennis Yi-Shin Kuo, MD,  Study Chair,  Cornell University Medical College   

Study ID Numbers:  CDR0000277249; NYWCCC-0902-492; NCI-5840; NCT00057863
Record last reviewed:  March 2003
Last Updated:  April 4, 2005
Record first received:  April 7, 2003
ClinicalTrials.gov Identifier:  NCT00057863
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08