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Philadelphia, Pennsylvania 19103


Purpose:

This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix. Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.


Study summary:

PRIMARY OBJECTIVES: I. Compare the survival and response of patients with stage IVB, recurrent, or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin. II. Compare the toxic effects of these regimens in these patients. III. Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms. ARM I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. ARM II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. ARM III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. ARM IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study entry. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.


Criteria:

Inclusion Criteria: - Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix - Stage IVB, recurrent, or persistent disease - Not amenable to curative surgery and/or radiotherapy - At least 1 unidimensionally measurable lesion - At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan - Biopsy confirmation required if lesion is less than 30 mm - Target lesion must be outside of a previously irradiated field - No craniospinal metastases - Performance status - GOG 0-1 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Bilirubin no greater than 1.5 times normal - Alkaline phosphatase no greater than 3 times normal - AST no greater than 3 times normal - Creatinine ≤ 1.2 mg/dL - Creatinine > 1.2 mg/dL but < 1.5 mg/dL AND creatinine clearance ≥ 50 mL/min - No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous drainage - Not pregnant or nursing - Fertile patients must use effective contraception - No prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer - No prior malignancy whose treatment contraindicates the current study therapy - No concurrent clinically significant infection - No concurrent cytokines - At least 6 weeks since prior chemoradiotherapy and recovered - No prior chemotherapy (except when concurrently administered with radiotherapy) - At least 3 weeks since prior radiotherapy and recovered - Recovered from prior surgery


Study is Available At:


Original ID:

GOG-0204


NCT ID:

NCT00064077


Secondary ID:

NCI-2012-02540


Study Acronym:


Brief Title:

Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervi


Official Title:

A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Gynecologic Oncology Group


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

513


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bradley Monk
Principal Investigator
Gynecologic Oncology Group

Study Dates

Start Date:May 2003
Completion Date:January 30, 2018
Completion Type:Actual
Primary Completion Date:January 2011
Primary Completion Type:Actual
Verification Date:August 2018
Last Changed Date:September 18, 2018
First Received Date:July 8, 2003
First Results Date:July 31, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).
Time Frame:Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
Safety Issues:False
Description:The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACI
Outcome Type:Secondary Outcome
Measure:Pain, Assessed by Brief Pain Inventory
Time Frame:Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
Safety Issues:False
Description:Single item from the Brief Pain Inventory (BPI) assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score.
Outcome Type:Secondary Outcome
Measure:Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)
Time Frame:Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
Safety Issues:False
Description:The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was score
Outcome Type:Secondary Outcome
Measure:Duration of Progression-free Survival (PFS)
Time Frame:Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months fo
Safety Issues:False
Description:Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as
Outcome Type:Secondary Outcome
Measure:Frequency of Response Using RECIST Version 1.0
Time Frame:Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months fo
Safety Issues:False
Description:RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in t
Outcome Type:Primary Outcome
Measure:Duration of Overall Survival (OS)
Time Frame:Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months fo
Safety Issues:False
Description:Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Study Interventions

Intervention Type:Drug
Name:Cisplatin
Description:Given IV
Arm Name:Arm I (paclitaxel, cisplatin)
Other Name:Abiplatin
Intervention Type:Drug
Name:Gemcitabine Hydrochloride
Arm Name:Arm III (gemcitabine, cisplatin)
Other Name:dFdCyd
Intervention Type:Drug
Name:Paclitaxel
Description:Given IV
Arm Name:Arm I (paclitaxel, cisplatin)
Other Name:Anzatax
Intervention Type:Other
Name:Quality-of-Life Assessment
Description:Ancillary studies
Arm Name:Arm I (paclitaxel, cisplatin)
Other Name:Quality of Life Assessment
Intervention Type:Drug
Name:Topotecan Hydrochloride
Description:Given IV
Arm Name:Arm IV (topotecan, cisplatin)
Other Name:Hycamptamine
Intervention Type:Drug
Name:Vinorelbine Tartrate
Description:Given IV
Arm Name:Arm II (vinorelbine, cisplatin)
Other Name:Biovelbin

Study Arms

Study Arm Type:Experimental
Arm Name:Arm IV (topotecan, cisplatin)
Description:Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.
Study Arm Type:Experimental
Arm Name:Arm III (gemcitabine, cisplatin)
Description:Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
Study Arm Type:Experimental
Arm Name:Arm II (vinorelbine, cisplatin)
Description:Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
Study Arm Type:Experimental
Arm Name:Arm I (paclitaxel, cisplatin)
Description:Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Gynecologic Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:22307062
Reference Type:Reference
Citation: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. Review.
PMID:20507804
Reference Type:Results Reference
Citation:Cella D, Huang HQ, Monk BJ, Wenzel L, Benda J, McMeekin DS, Cohn D, Ramondetta L, Boardman CH. Health-related quality of life outcomes associated with four cisplatin-based doublet chemotherapy regimens for stage IVB recurrent or persistent cervical cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2010 Dec;119(3):531-7. doi: 10.1016/j.ygyno.2010.08.020. Epub 2010 Sep 15.
PMID:20837359
Reference Type:Results Reference
Citation:Monk BJ, Sill MW, McMeekin DS, Cohn DE, Ramondetta LM, Boardman CH, Benda J, Cella D. Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2009 Oct 1;27(28):4649-55. doi: 10.1200/JCO.2009.21.8909. Epub 2009 Aug 31.
PMID:19720909
Reference Type:Results Reference
Citation:Monk BJ, Sill M, McMeekin DS, et al.: A randomized phase III trial of four cisplatin (CIS) containing doublet combinations in stage IVB, recurrent or persistent cervical carcinoma: a Gynecologic Oncology Group (GOG) study. [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA5504, 2008.
Reference Type:Results Reference
Citation:Wenzel LB, Huang H, Cella D, et al.: Quality-of-life results of a randomized phase III trial of four cisplatin (Cis) containing doublet combinations in stage IVB cervical carcinoma: A gynecologic oncology group (GOG) study. [Abstract] J Clin Oncol 26 (Suppl 15): A-5529, 2008.

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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