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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00003945




Registration number
NCT00003945
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
27/05/2013

Titles & IDs
Public title
Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
Scientific title
A Randomized Phase III Study of Cisplatin Versus Cisplatin Plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix
Secondary ID [1] 0 0
GOG-0179
Secondary ID [2] 0 0
CDR0000067138
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cisplatin
Treatment: Drugs - topotecan hydrochloride

Treatment: Drugs: cisplatin


Treatment: Drugs: topotecan hydrochloride
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed stage IVB, recurrent, or persistent carcinoma of the cervix
that is not amenable to curative treatment with surgery and/or radiotherapy

- Eligible subtypes:

- Squamous cell carcinoma

- Adenosquamous carcinoma

- Adenocarcinoma

- Measurable disease by physical examination, radiography, CT scan, or MRI

- Measurable disease by CT scan/MRI without biopsy confirmation allowed if lesions
are at least 3 cm and well defined

- No craniospinal metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- Alkaline phosphatase no greater than 3 times normal

Renal:

- Creatinine no greater than 1.5 mg/dL

- No bilateral hydronephrosis that cannot be alleviated by ureteral stents or
percutaneous drainage

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No clinically significant infection

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

- Body surface area no greater than 2.0 m^2

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 6 weeks since prior chemoradiotherapy and recovered

- No prior chemotherapy except when used concurrently with radiotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- See Chemotherapy

- At least 3 weeks since prior radiotherapy only and recovered

Surgery:

- Recovered from prior surgery

Other:

- No prior anticancer treatment that would preclude study therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Indiana
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Nebraska
Country [4] 0 0
United States of America
State/province [4] 0 0
New Mexico
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Wisconsin
Country [7] 0 0
Peru
State/province [7] 0 0
Lima
Country [8] 0 0
Puerto Rico
State/province [8] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Other
Name
Gynecologic Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Eastern Cooperative Oncology Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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 which chemotherapy regimen is more effective for cervical cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of three different
chemotherapy regimens in treating patients with stage IVB, recurrent, or persistent cervical
cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00003945
Trial related presentations / publications
Chase DM, Huang HQ, Wenzel L, Cella D, McQuellon R, Long HJ, Moore DH, Monk BJ. Quality of life and survival in advanced cervical cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 May;125(2):315-9. doi: 10.1016/j.ygyno.2012.01.047. Epub 2012 Feb 1.
Moore DH, Tian C, Monk BJ, Long HJ, Omura GA, Bloss JD. Prognostic factors for response to cisplatin-based chemotherapy in advanced cervical carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2010 Jan;116(1):44-9. doi: 10.1016/j.ygyno.2009.09.006. Epub 2009 Oct 22.
Paton F, Paulden M, Saramago P, Manca A, Misso K, Palmer S, Eastwood A. Topotecan for the treatment of recurrent and stage IVB carcinoma of the cervix. Health Technol Assess. 2010 May;14 Suppl 1:55-62. doi: 10.3310/hta14Suppl1/08.
Plaxe SC, Brooks SE, Tian C, Bloss JD, Moore DH, Long HJ. Influence of race on tolerance of platinum-based chemotherapy and clinical outcomes in women with advanced and recurrent cervical cancer: a pooled analysis of 3 Gynecologic Oncology Group studies. Am J Obstet Gynecol. 2008 Nov;199(5):539.e1-6. doi: 10.1016/j.ajog.2008.04.038. Epub 2008 Jun 20.
Moore DH, Tian C, Monk BJ, et al.: Factors predictive of response to cisplatin-based chemotherapy in stage IVB persistent or recurrent cervical carcinoma: a multivariate analysis of three Gynecologic Oncology Group trials. [Abstract] J Clin Oncol 25 (Suppl 18): A-5534, 282s, 2007.
Tewari KS, Monk BJ. Gynecologic oncology group trials of chemotherapy for metastatic and recurrent cervical cancer. Curr Oncol Rep. 2005 Nov;7(6):419-34. doi: 10.1007/s11912-005-0007-z.
Public notes

Contacts
Principal investigator
Name 0 0
Harry J. Long, MD
Address 0 0
Mayo Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00003945