Comparison of Cisplatin Combined With Either Paclitaxel or Gemcitabine in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer - Full Text View

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. It is not yet known whether cisplatin is more effective when combined with paclitaxel or gemcitabine in treating cervical cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with paclitaxel to that of cisplatin combined with gemcitabine in treating women who have recurrent, persistent, or metastatic cervical cancer.

Condition	Intervention	Phase
Cervical Cancer	Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel	Phase III

MedlinePlus related topics:

Cancer Cervical Cancer

ChemIDplus related topics:

Cisplatin Gemcitabine hydrochloride Gemcitabine Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control

Official Title:	Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix

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

Study Start Date:

April 2003

Detailed Description:

OBJECTIVES:

Compare the overall survival, progression-free survival, and objective response rate (confirmed and unconfirmed, complete and partial) of patients with recurrent, persistent, or metastatic cervical cancer treated with cisplatin and paclitaxel vs cisplatin and gemcitabine.
Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status at study entry (metastatic vs recurrent vs persistent), prior cisplatin as a radiosensitizer (yes vs no), and extent of disease (confined to pelvis vs extrapelvic disease). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 2 hours on day 2.
Arm II:Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 2 hours on day 1.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 4 years.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of primary carcinoma of the cervix, meeting 1 of the following staging criteria:
- Metastatic (stage IVB)
- Recurrent after prior complete response to primary treatment with surgery or radiotherapy
- Persistent after surgery or radiotherapy
Measurable disease

PATIENT CHARACTERISTICS:

Age

Not specified

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Creatinine less than upper limit of normal OR
Creatinine clearance greater than 40 mL/min

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No grade 2 or greater sensory or motor neuropathy
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

More than 6 months since prior single-agent chemotherapy as a radiosensitizer

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
At least 28 days since prior radiotherapy
No prior radiotherapy to measurable target lesions
No concurrent palliative radiotherapy

Surgery

See Disease Characteristics
Recovered from prior surgery

Other

No prior systemic therapy
No other concurrent antitumor therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057928

Show 106 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators


Study Chair:	Harry J. Long, MD	Mayo Clinic

More Information

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

Study ID Numbers:	CDR0000285630, SWOG-S0227
First Received:	April 7, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00057928
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent cervical cancer

stage IVB cervical cancer

Study placed in the following topic categories:

Genital Diseases, Female

Uterine Cervical Neoplasms

Uterine Cervical Diseases

Cisplatin

Paclitaxel

Genital Neoplasms, Female

Uterine Diseases

Uterine Neoplasms

Urogenital Neoplasms

Gemcitabine

Recurrence

Carcinoma

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Mitosis Modulators

Physiological Effects of Drugs

Enzyme Inhibitors

Antimitotic Agents

Immunosuppressive Agents

Antiviral Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Radiation-Sensitizing Agents

Therapeutic Uses

Tubulin Modulators

Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00057928