Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer - Full Text View

Sponsor:	Albert Einstein College of Medicine of Yeshiva University
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

Drug Information available for: Paclitaxel Oxaliplatin

U.S. FDA Resources

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

Additional Information:

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

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kuo DY, Blank SV, Christos PJ, Kim M, Caputo TA, Pothuri B, Hershman D, Goldman N, Ivy PS, Runowicz CD, Muggia F, Goldberg GL, Einstein MH. Paclitaxel plus oxaliplatin for recurrent or metastatic cervical cancer: a New York Cancer Consortium Study. Gynecol Oncol. 2010 Mar;116(3):442-6. Epub 2009 Nov 20.

ClinicalTrials.gov Identifier:	NCT00057863 History of Changes
Other Study ID Numbers:	CDR0000277249, AECM-0902492, NCI-5840
Study First Received:	April 7, 2003
Last Updated:	September 17, 2008
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

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Oxaliplatin

Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 12, 2012