Etoposide for Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Indiana University Melvin & Bren Simon Cancer Center, Indianapolis, IN
Cancer+4 More
Etoposide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a drug may help prevent cancer from returning in individuals who have already had cancer.

See full description

Eligible Conditions

  • Cancer
  • Neoplasms
  • Germ Cell Cancer
  • Neoplasms, Germ Cell and Embryonal
  • Non Seminomatous Germ Cell Tumors
  • Ovarian germ cell tumour
  • Germ Cell Tumors

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Etoposide will improve 1 primary outcome and 2 secondary outcomes in patients with Cancer. Measurement will happen over the course of time from the date of randomization to the date of disease relapse or death (i.e. up to 1 year).

Year 1
12-month Overall Survival
Year 2
Assess toxicity and tolerability of maintenance etoposide
Year 1
12-month Progression Free Survival

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

Arm B (Stanford V)
Anemia
98%
Leukocytes decreased
93%
Lymphopenia
90%
Neutrophils decreased
84%
Neuropathy-sensory
78%
Alopecia
75%
Fatigue
74%
Nausea
67%
Hyperglycemia
60%
Constipation
52%
Hypoalbuminemia
46%
Myalgia
40%
Stomatitis
34%
Insomnia
33%
Vomiting
32%
Platelets decreased
27%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
26%
Dyspnea
23%
Dyspepsia
20%
Dysphagia
19%
Headache
19%
Arthralgia
16%
Anorexia
16%
Neuropathy-motor
15%
Abdominal pain
15%
Fever
14%
Infection w/o neutropenia
14%
Cough
14%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
13%
Bone pain
12%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
11%
Radiation dermatitis
10%
Sweating
10%
Rigors/chills
9%
Injection site reaction
9%
Dizziness/lightheadedness
9%
Chest pain
8%
Phlebitis
8%
Pain-other
8%
Blood bilirubin increased
8%
Dysphagia-esophageal radiation
8%
Hypoglycemia
8%
Edema
7%
Pruritus
7%
Creatinine increased
7%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
6%
Mouth dryness
5%
Depression
5%
Muscle weakness
5%
Pneumonitis/pulmonary infiltrates
4%
Transfusion: pRBCs
4%
Nail changes
3%
Irregular menses
3%
Febrile neutropenia
3%
Thrombosis/embolism
3%
Allergic rhinitis
2%
Syncope
1%
Sinus tachycardia
1%
Infection w/ unknown ANC
1%
Neuropathic pain
1%
Allergic reaction
1%
Dehydration
1%
Peripheral arterial ischemia
0%
Pain due to radiation
0%
Hypocalcemia
0%
Urticaria
0%
Supraventricular arrhythmias
0%
(DLCO) decreased
0%
Hypotension
0%
(ARDS)
0%
Mucositis due to radiation
0%
Allergy-other
0%
Pericardial effusion/pericarditis
0%
Conduction abnormality
0%
Middle ear/hearing
0%
Voice changes/stridor
0%
Hand-foot reaction
0%
Ileus
0%
Catheter-related infection
0%
Ataxia
0%
Urinary frequency/urgency
0%
Neuropathy-cranial
0%
Melena/GI bleeding
0%
Extrapyramidal movement
0%
Dysmenorrhea
0%
Alanine aminotransferase increased
0%
Pancreatitis
0%
Gastritis
0%
Cardiac-other
0%
Hematemesis
0%
Pulmonary fibrosis
0%
Delusions
0%
FEV1 decreased
0%
Hiccoughs
0%
Cardiac-left ventricular function
0%
Endocrine-other
0%
Hypothyroidism
0%
Male infertility
0%
Hypoxia
0%
Vertigo
0%
Blurred vision
0%
Incontinence
0%
Cardiac-ischemia
0%
Coagulation-other
0%
Colitis
0%
Renal/GU-other
0%
Hypertension
0%
Pulmonary-other
0%
Hypokalemia
0%
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT00003389) in the Arm B (Stanford V) ARM group. Side effects include: Anemia with 98%, Leukocytes decreased with 93%, Lymphopenia with 90%, Neutrophils decreased with 84%, Neuropathy-sensory with 78%.

Trial Design

2 Treatment Groups

Control
Maintenance Oral Etoposide

This trial requires 64 total participants across 2 different treatment groups

This trial involves 2 different treatments. Etoposide is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Maintenance Oral Etoposide
Drug
Maintenance daily oral Etoposide.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion (i.e. up to 2 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion (i.e. up to 2 years) for reporting.

Closest Location

Indiana University Melvin & Bren Simon Cancer Center - Indianapolis, IN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer or one of the other 4 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Relapsed disease after first-line cisplatin-based combination chemotherapy
Histological or serological evidence of non-seminomatous GCT
Written informed consent and HIPAA authorization for release of personal health information
Age ≥ 18 years at the time of consent
Completed salvage treatment with HDCT and PBSCT for 2 tandem cycles per Institutional Guidelines
HDCT must have been used as the initial salvage chemotherapy regimen (2nd line therapy) 6.1. Note: 1 or 2 cycles of standard course regimens prior to HDCT are acceptable (regimens include VeIP [vinblastine+ifosfmaide+cisplatin] or TIP [paclitaxel+ifosfamide+cisplatin] or PVB [cisplatin+vinblastine+bleomycin]
Normal or declining tumor markers (AFP and hCG) at time of screening
Adverse events from prior therapy recovered to CTCAE v5.0 grade ≤ 2 at time of registration
Women with ovarian germ cell tumors are eligible
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 28 days of study registration

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can cancer be cured?

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Although cancer is technically technically cureable, only a small minority of patients will have their cancers or life-threatening disease cured. Current chemotherapeutic treatment approaches cannot cure or prevent cancer. Although cures have sometimes been claimed, there are no cures for cancer.

Unverified Answer

What is cancer?

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The word cancer is an archaic term from the Latin word kome (from κόμη/κωμες, "kome/kōmēs", "a swelling or lump"). The word cancer appears for the first time in Arabic-speaking medical literature at the beginning of the 12th century, in 'al-Tasrif by Yaqut al-Hamawi (d. 1186). When a tumor is encountered in the medical literature, it is called cancer. A typical tumor is a lump or swelling in one or more parts of the body.\nhttps://www.medxipedia.com/doi/full/10.

Unverified Answer

What are common treatments for cancer?

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The use of multiple conventional cancer treatments is common in older people and is associated with increased risk of death. Alternative treatments may be useful in older people with cancer in terms of improvement in quality of life, functional status, and anticancer treatment side-effects. However, clinical research is limited and requires further investigation.

Unverified Answer

What causes cancer?

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The cause of cancer may have multiple causes, and research efforts to discover the causes may be overworked. It is necessary to find a new way to think about the causation of cancer, and to reduce or eliminate the various causes from the epidemiology of cancer.

Unverified Answer

How many people get cancer a year in the United States?

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2,850,000 to 6,100,000 new diagnoses of cancer will be made a year in the United States. The American Cancer Society estimates that 1 in 50 men, and 1 in 80 women, in the United States will be diagnosed with some form of cancer by the year 2037.

Unverified Answer

Is etoposide typically used in combination with any other treatments?

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Use of etoposide with other therapies was most common in patients with myelodysplastic syndrome (MDS), aplastic anaemia, chronic myelomonocytic leukaemia and advanced non-Hodgkin's lymphoma. Patients with AL amyloidosis and AL K-ras mutations were most likely to be treated with etoposide and a myelosuppressive agent, whereas patients with AL with the FH5LTR mutation were more likely to receive etoposide alone.

Unverified Answer

What is the primary cause of cancer?

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These data seem to imply that the primary cause of cancer is an aneuploidy, a chromosomal aberration involving the entire genome of cells. It is postulated that such changes result in a loss of normal gene control. This change, rather than a mutation of an inherited sequence such as DNA or a gene, is the cause of cancer. The implication is that DNA damage caused by the aneuploidy is the cause of cancer. One possible mechanism of aneuploidy-induced chromosomal instability is that cancer cells have an excess of DNA damage-repair proteins compared to healthy noncancer cells.

Unverified Answer

What is the survival rate for cancer?

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The 5-year survival rate for cancer is 40 percent. Survival time depends enormously upon the cancer type diagnosed and its grade, or stage. The more recent 5-year survival rate for lung cancer in women has been consistently rising since a surge in the 1970-1980s. 5-year survival on average has been increasing. Lung adenocarcinoma (which is the most common type of lung cancer in females) has been shown to be the tumor which has the highest 5-year survival in women (66 percent in 2000 compared with 50 percent in 1955) and in men (64 percent in 2000 compared with 55 percent in 1955).

Unverified Answer

How serious can cancer be?

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The severity of a cancers depends on two major factors: the type of cancer and the age of the person. For example, even a person who has only been diagnosed with breast cancer is at risk, as the brain remains responsive to hormones even after all cancer has been surgically removed from the body. Likewise, the younger a person is, the more severely his or her cancer will progress. People whose cancer hasn't penetrated into a major organ will be able to live a relatively normal life and will not necessarily be as likely to die of the cancer or any complications connected to the onset of the cancer.

Unverified Answer

How does etoposide work?

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Data from a recent study provide strong support for the notion that etoposide induces a complex cascade of protein degradation events that culminate in the proteasome-dependent degradation of multiple targets.

Unverified Answer

Who should consider clinical trials for cancer?

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The evidence in the literature does not support the assumption that a large part of the population would be willing or able to join the clinical trials of an experimental chemotherapy regimen given to only the 20% of patients who would be eligible for the trial. In our study population, patients with more experience and in whom the prognosis is not so dire, were less enthusiastic about trials.

Unverified Answer
See if you qualify for this trial
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