What side effects are associated with this type of intervention?

Common treatments for thymic carcinoma, such as carboplatin and paclitaxel, often cause side effects including nausea, vomiting, hair loss, fatigue, and an increased risk of infection due to lowered white blood cell counts. Ramucirumab, a monoclonal antibody, can lead to hypertension, diarrhea, and an increased risk of bleeding and gastrointestinal perforations. Patients may also experience infusion-related reactions such as fever, chills, and rash. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for thymic carcinoma that directly match the profile of Ramucirumab, a monoclonal antibody that interferes with tumor cell growth and spread. However, treatments for thymic carcinoma often involve chemotherapy agents such as carboplatin and paclitaxel, which are being studied in combination with Ramucirumab in clinical trials. Other monoclonal antibodies and targeted therapies are being explored in various cancers, but specific approvals for thymic carcinoma remain limited.

What other types of research exist?

Promising novel alternatives to Ramucirumab for Thymic Carcinoma patients in 2024 include Pembrolizumab and Atezolizumab. Both are immune checkpoint inhibitors that have shown efficacy in various cancers by enhancing the body's immune response against tumor cells. Additionally, targeted therapies like Sunitinib and Cabozantinib, which inhibit multiple tyrosine kinases involved in tumor growth and angiogenesis, may also be considered.

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Platinum-based Chemotherapy

Chemotherapy +/− Ramucirumab for Thymic Cancer

Phase 2

Waitlist Available

Led By Anne S Tsao

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have unresectable thymic carcinoma, that is either locally advanced, recurrent, or metastatic

Patients must have a Zubrod performance status of 0 to 2

Must not have

Cirrhosis at a level of Child-Pugh B (or worse)

Cirrhosis (any degree) and a history of hepatic encephalopathy; or

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding ramucirumab to standard chemotherapy helps treat advanced thymic cancer better than chemotherapy alone. It targets patients whose cancer has spread, returned, or can't be surgically removed. The chemotherapy drugs kill or stop the growth of cancer cells, while ramucirumab blocks tumor growth signals. Ramucirumab has shown positive results in combination with paclitaxel for advanced gastric cancer.

Who is the study for?

This trial is for adults with advanced, recurrent, or metastatic thymic cancer that can't be surgically removed. They should not have had previous systemic anti-cancer therapy for this condition and must have measurable disease. Participants need proper liver and kidney function, no significant blood clots or bleeding in recent months, controlled blood pressure, and cannot be pregnant or breastfeeding.

What is being tested?

The study compares the effectiveness of chemotherapy drugs carboplatin and paclitaxel alone versus combined with ramucirumab (a monoclonal antibody) in treating thymic cancer. The goal is to see if adding ramucirumab improves treatment outcomes compared to just chemotherapy.

What are the potential side effects?

Possible side effects include allergic reactions to the drugs, increased risk of infection due to lowered white blood cell counts, nausea, fatigue from chemotherapy agents like carboplatin and paclitaxel; ramucirumab may cause high blood pressure, bleeding problems including gastrointestinal bleeds or wound healing complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My thymic carcinoma cannot be removed by surgery and has spread.

Select...

I can take care of myself and am up and about more than 50% of my waking hours.

Select...

I cannot have surgery to remove my cancer.

Select...

I have not received any systemic anti-cancer treatments for my advanced thymic carcinoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My liver disease is severe (Child-Pugh B or worse).

Select...

I have liver cirrhosis and a history of brain issues due to it.

Select...

I haven't had a heart attack, stroke, or similar event in the last 6 months.

Select...

My blood pressure has been under control with medication.

Select...

I have significant fluid buildup in my abdomen due to liver cirrhosis needing medication or drainage.

Select...

I haven't coughed up blood or have a tumor invading major blood vessels.

Select...

I am not on regular blood thinning medication, except for possibly low-dose aspirin.

Select...

My recent urine tests show low protein levels.

Select...

I have not had any serious gut issues or risks for them in the last 6 months.

Select...

I haven't had any serious wounds, ulcers, or broken bones in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Disease control rate (complete response, partial response, confirmed or unconfirmed, stable disease)

Incidence of adverse events

Overall survival

+1 more

Side effects data

From 2016 Phase 3 trial • 1253 Patients • NCT01168973

46%

Fatigue

36%

Neutropenia

32%

Diarrhoea

30%

Decreased appetite

27%

Nausea

26%

Alopecia

24%

Dyspnoea

23%

Stomatitis

22%

Cough

22%

Anaemia

19%

Epistaxis

18%

Neutrophil count decreased

17%

Oedema peripheral

17%

Constipation

16%

Mucosal inflammation

16%

Pyrexia

14%

Lacrimation increased

14%

Vomiting

14%

Febrile neutropenia

13%

Myalgia

13%

Leukopenia

12%

Back pain

12%

Peripheral sensory neuropathy

11%

Headache

11%

Arthralgia

11%

Dysgeusia

11%

Insomnia

11%

Hypertension

11%

Asthenia

11%

Weight decreased

Abdominal pain

White blood cell count decreased

Pain in extremity

Oropharyngeal pain

Thrombocytopenia

Rash

Nail discolouration

Dizziness

Pain

Hyperglycaemia

Dyspepsia

Dehydration

Dysphonia

Paraesthesia

Haemoptysis

Productive cough

Pneumonia

Platelet count decreased

Bone pain

Chronic obstructive pulmonary disease

Hyponatraemia

Lobar pneumonia

Metastatic pain

Pleural effusion

Pneumothorax

Pulmonary embolism

Pulmonary haemorrhage

Syncope

Confusional state

Death

Atrial fibrillation

General physical health deterioration

Renal failure acute

100%

80%

60%

40%

20%

Study treatment Arm

Ramucirumab and Docetaxel

Placebo and Docetaxel

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (ramucirumab, carboplatin, paclitaxel)Experimental Treatment3 Interventions

Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.

Group II: Arm B (carboplatin, paclitaxel)Active Control2 Interventions

Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Ramucirumab

2017

Completed Phase 3

~5050

Paclitaxel

2011

Completed Phase 4

~5370

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Thymic Carcinoma include chemotherapy agents such as carboplatin and paclitaxel, and monoclonal antibodies like ramucirumab. Chemotherapy drugs work by killing tumor cells, stopping them from dividing, or preventing them from spreading. Ramucirumab, a monoclonal antibody, interferes with the ability of tumor cells to grow and spread by targeting specific proteins involved in angiogenesis (formation of new blood vessels that supply the tumor). This combination is significant for Thymic Carcinoma patients as it offers a multi-faceted approach to inhibit tumor growth and dissemination, potentially improving treatment outcomes for those with advanced or inoperable disease.

Angiogenesis inhibitors in early development for gastric cancer.The State of Immune Checkpoint Inhibition in Urothelial Carcinoma: Current Evidence and Future Areas of Exploration.