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Taxane

Quality-of-Life Assessment for Fallopian Tube Cancer

Phase 3
Waitlist Available
Led By Larry J Copeland
Research Sponsored by GOG Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next five years.
Awards & highlights

Study Summary

This trial is studying paclitaxel to see how well it works compared to polyglutamate paclitaxel or observation only in treating patients with stage III or stage IV ovarian epithelial, peritoneal cancer, or fallopian tube cancer.

Eligible Conditions
  • Fallopian Tube Cancer
  • Ovarian Carcinoma
  • Fallopian Tube Adenocarcinoma
  • Peritoneal Cancer
  • Peritoneal Serous Adenocarcinoma
  • Ovarian Adenocarcinoma
  • Fallopian Tube Carcinoma
  • Endometrioid Adenocarcinoma
  • Ovarian Cancer
  • Ovarian Brenner Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1. prior to treatment 2. prior to cycle 3 3. prior to cycle 5 4. prior to cycle 7 5. prior to cycle 12 6. 12 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1. prior to treatment 2. prior to cycle 3 3. prior to cycle 5 4. prior to cycle 7 5. prior to cycle 12 6. 12 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Secondary outcome measures
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0
Patient-Reported Peripheral Neuropathy Symptoms
Patient-Reported Quality of Life (QOL)
+1 more

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181
73%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Acute kidney injury
2%
Blurred vision
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (observation)Experimental Treatment3 Interventions
Patients receive no further anticancer treatment until evidence of disease progression.
Group II: Arm I (paclitaxel poliglumex)Experimental Treatment3 Interventions
Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Group III: Arm II (paclitaxel)Active Control3 Interventions
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quality-of-Life Assessment
2017
Completed Phase 3
~4950
Glutamic acid
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,682 Previous Clinical Trials
40,927,546 Total Patients Enrolled
GOG FoundationLead Sponsor
42 Previous Clinical Trials
15,584 Total Patients Enrolled
Larry J CopelandPrincipal InvestigatorNRG Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer
2005. "Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00108745.
All > Acl
~58 spots leftby May 2025
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