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

NCT ID: NCT00064077

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 513 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2018-01-30

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (paclitaxel, cisplatin)

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

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

Given IV

Paclitaxel

Intervention Type: DRUG

Given IV

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Arm II (vinorelbine, cisplatin)

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

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

Given IV

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Vinorelbine Tartrate

Intervention Type: DRUG

Given IV

Arm III (gemcitabine, cisplatin)

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

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

Given IV

Gemcitabine Hydrochloride

Intervention Type: DRUG

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Arm IV (topotecan, cisplatin)

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

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

Given IV

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Topotecan Hydrochloride

Intervention Type: DRUG

Given IV

Interventions

Cisplatin

Given IV

Intervention Type: DRUG

Gemcitabine Hydrochloride

Intervention Type: DRUG

Paclitaxel

Given IV

Intervention Type: DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Topotecan Hydrochloride

Given IV

Intervention Type: DRUG

Vinorelbine Tartrate

Given IV

Intervention Type: DRUG

Other Intervention Names

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; dFdCyd; Difluorodeoxycytidine Hydrochloride; Gemzar; LY-188011; Anzatax; Asotax; Bristaxol; Praxel; Taxol; Taxol Konzentrat; Quality of Life Assessment; Hycamptamine; Hycamtin; SKF S-104864-A; Topotecan HCl; topotecan hydrochloride (oral); Biovelbin; Eunades; KW-2307; Navelbine; Navelbine Ditartrate; NVB; Vinorelbine Ditartrate

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradley Monk

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2012-02540

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000306463

Identifier Type: -

Identifier Source: secondary_id

GOG-0204

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0204

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-0204

Identifier Type: -

Identifier Source: org_study_id