Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	AECM-0902492 NCI-5840, NCT00057863, 5840

Objectives

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

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

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

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/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

Overall objective response rate (complete and partial response)

Progression-free survival
Overall survival

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.

Trial Contact Information

Trial Lead Organizations

Albert Einstein Cancer Center at Albert Einstein College of Medicine

Dennis Kuo, MD, Protocol chair		Ph: 718-405-8082 Email: dykuo@montefiore.org

Registry Information
Official Title		A Phase II Study Of Oxaliplatin In Combination With Paclitaxel In Patients With Locally Recurrent Or Metastatic Cervical Cancer
Trial Start Date		2003-02-28
Trial Completion Date		2004-06-22 (estimated)
Registered in ClinicalTrials.gov		NCT00057863
Date Submitted to PDQ		2003-01-24
Information Last Verified		2008-07-10

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