Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Cisplatin — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Paclitaxel — DRUG
  Given IV
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies
• Topotecan Hydrochloride — DRUG
  Given IV

Study Details

This randomized phase III trial studies the side effects of paclitaxel when given together with cisplatin or topotecan with or without bevacizumab and to compare how well they work in treating patients with stage IVB, cervical cancer that has come back or is persistent. Drugs used in chemotherapy, such as paclitaxel, cisplatin, and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether paclitaxel is more effective when given together with cisplatin or topotecan with or without bevacizumab in treating patients with cervical cancer.

Key Dates

First listed

Dec 5, 2008

Start date

Apr 30, 2009

Status verified

Jul 2019

Primary completion

Feb 28, 2013

Completion

Feb 28, 2013

Study Design

Enrollment

452 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (paclitaxel and cisplatin)
  Patients receive paclitaxel IV over 3 hours or 24 hours on day 1 and cisplatin IV on day 1 or 2.
• Experimental: Arm II (paclitaxel, cisplatin, bevacizumab)
  Patients receive paclitaxel IV over 3 hours or 24 hours on day 1 and cisplatin IV and bevacizumab IV over 30-90 minutes on day 1 or 2.
• Experimental: Arm III (topotecan hydrochloride and paclitaxel)
  Patients receive paclitaxel IV over 3 hours on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3.
• Experimental: Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab)
  Patients receive paclitaxel IV over 3 hours and bevacizumab IV over 30-90 minutes on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3.

Primary Outcome Measure

Overall Survival [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 5 years ]

Locations (541)

Find similar trials in Birmingham, AL

Related Studies

• Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers
  PHASE1 · Recruiting · M.D. Anderson Cancer Center · Baltimore, Maryland
• PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
  PHASE2 · Recruiting · Precigen, Inc · Little Rock, Arkansas
• Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform
  Recruiting · Mayo Clinic · Phoenix, Arizona
• External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for the Treatment of Stage IVB Cervical Cancer
  PHASE1/PHASE2 · Recruiting · Jonsson Comprehensive Cancer Center · Los Angeles, California