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A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix


Phase 2
N/A
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix


OBJECTIVES:

- Determine the antitumor activity of doxorubicin HCl liposome in patients with
persistent or recurrent squamous cell carcinoma of the cervix.

- Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin HCl liposome IV over 1 hour on day 1. Treatment repeats every
28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma (SCC) of the cervix

- Persistent or recurrent progressive disease

- Must have failed local therapeutic measures and considered incurable

- 1 prior chemotherapeutic regimen for SCC of the cervix required

- Initial treatment may include high-dose therapy, consolidation, or extended
therapy

- Ineligible for a higher priority GOG protocol

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR

- At least 10 mm by spiral CT scan

- Target lesion may not be within a previously irradiated field

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Platelet count at least 100,000/mm3

- Absolute neutrophil count at least 1,500/mm3

Hepatic:

- Bilirubin no greater than upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No congestive heart failure

- No unstable angina

- No myocardial infarction or new cardiac arrhythmia in the past 6 months

Other:

- No active infection requiring antibiotics

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- 1 prior noncytotoxic biologic regimen (e.g., monoclonal antibodies, cytokines, or
small-molecule inhibitors of signal transduction) allowed for recurrent or persistent
disease (provided patient has not received a noncytotoxic cytostatic regimen for
recurrent or persistent disease management)

- At least 3 weeks since prior biologic or immunologic therapy for SCC of the cervix

Chemotherapy:

- See Disease Characteristics

- No prior doxorubicin or doxorubicin HCl liposome

- 1 prior noncytotoxic cytostatic regimen allowed for recurrent or persistent disease
(provided patient has not received a noncytotoxic biologic regimen for recurrent or
persistent disease management)

- No other prior cytotoxic chemotherapy for recurrent or persistent disease, including
retreatment with initial chemotherapy regimens

- Recovered from prior chemotherapy

Endocrine therapy:

- At least 1 week since prior hormonal therapy for SCC of the cervix

- Concurrent hormone replacement therapy allowed

Radiotherapy:

- See Disease Characteristics

- Recovered from prior radiotherapy

Surgery:

- Recovered from prior surgery

Other:

- At least 3 weeks since other prior therapy for SCC of the cervix

- No prior anticancer treatment that precludes study

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter G. Rose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

MetroHealth Cancer Care Center at MetroHealth Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000069168

NCT ID:

NCT00030472

Start Date:

December 2001

Completion Date:

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • cervical squamous cell carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
MBCCOP - HawaiiHonolulu, Hawaii  96813
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Abington Memorial HospitalAbington, Pennsylvania  19001
Community Hospital of Los GatosLos Gatos, California  95032
University of Texas Medical BranchGalveston, Texas  77555-1329
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Cooper University HospitalCamden, New Jersey  08103
Tufts - New England Medical CenterBoston, Massachusetts  02111
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
University of Texas M.D. Anderson CCOP Research BaseHouston, Texas  77030-4009