Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix
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ClinicalTrials.gov Identifier: NCT00030472 |
Recruitment Status :
Terminated
First Posted : January 27, 2003
Last Update Posted : April 11, 2013
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness liposomal doxorubicin in treating patients who have persistent or recurrent cancer of the cervix.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Cancer | Drug: pegylated liposomal doxorubicin hydrochloride | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix |
Study Start Date : | December 2001 |
Actual Primary Completion Date : | October 2006 |


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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030472

Study Chair: | Peter G. Rose, MD | MetroHealth Cancer Care Center at MetroHealth Medical Center |
ClinicalTrials.gov Identifier: | NCT00030472 |
Other Study ID Numbers: |
CDR0000069168 GOG-0127R |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | April 11, 2013 |
Last Verified: | September 2004 |
recurrent cervical cancer stage IVB cervical cancer cervical squamous cell carcinoma |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |
Doxorubicin Liposomal doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |