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

NCT00064077 | Completed Phase 3 Results

• 4 other identifiers: GOG-0204NCI-2012-02540CDR0000306463U10CA027469
• Study Type: interventional
• Target: 513
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma; Recurrent Cervical Carcinoma; Stage IVB Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Duration of Overall Survival (OS)

  Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

  Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

Secondary Outcomes (5)

• Frequency of Response Using RECIST Version 1.0

  Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

• Duration of Progression-free Survival (PFS)

  Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

• Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)

  Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

• Pain, Assessed by Brief Pain Inventory

  Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

• Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).

  Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

Study Arms (4)

Arm I (paclitaxel, cisplatin)

EXPERIMENTAL

Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.

Drug: Cisplatin; Drug: Paclitaxel; Other: Quality-of-Life Assessment

Arm II (vinorelbine, cisplatin)

EXPERIMENTAL

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.

Drug: Cisplatin; Other: Quality-of-Life Assessment; Drug: Vinorelbine Tartrate

Arm III (gemcitabine, cisplatin)

EXPERIMENTAL

Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.

Drug: Cisplatin; Drug: Gemcitabine Hydrochloride; Other: Quality-of-Life Assessment

Arm IV (topotecan, cisplatin)

EXPERIMENTAL

Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

Drug: Cisplatin; Other: Quality-of-Life Assessment; Drug: Topotecan Hydrochloride

Interventions

Cisplatin DRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Arm I (paclitaxel, cisplatin); Arm II (vinorelbine, cisplatin); Arm III (gemcitabine, cisplatin); Arm IV (topotecan, cisplatin)

Gemcitabine Hydrochloride DRUG

Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011

Arm III (gemcitabine, cisplatin)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Arm I (paclitaxel, cisplatin)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (paclitaxel, cisplatin); Arm II (vinorelbine, cisplatin); Arm III (gemcitabine, cisplatin); Arm IV (topotecan, cisplatin)

Topotecan Hydrochloride DRUG

Given IV

Also known as: Hycamptamine, Hycamtin, SKF S-104864-A, Topotecan HCl, topotecan hydrochloride (oral)

Arm IV (topotecan, cisplatin)

Vinorelbine Tartrate DRUG

Given IV

Also known as: Biovelbin, Eunades, KW-2307, Navelbine, Navelbine Ditartrate, NVB, Vinorelbine Ditartrate

Arm II (vinorelbine, cisplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Gemcitabine; Paclitaxel; Taxes; Topotecan; Vinorelbine

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Camptothecin; Alkaloids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Angela Kuras on behalf of Michael Sill and Helen Huang
• Organization: NRG Oncology

kurasa@nrgoncology.org

716-845-5702

Study Officials

• Bradley Monk

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2003
• First Posted: July 9, 2003
• Study Start: May 1, 2003
• Primary Completion: January 1, 2011
• Study Completion: January 30, 2018
• Last Updated: October 17, 2018
• Results First Posted: August 28, 2018

Record last verified: 2018-08

Locations

US (1)