Doxorubicin for Soft Tissue Sarcoma

Princess Margaret Cancer Centre, Toronto, Canada

Soft Tissue Sarcoma+2 More ConditionsDoxorubicin - Drug

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Eligibility

No minimum age - 64

All Sexes

Eligibility

No minimum age - 64

All Sexes

Study Summary

This trial is testing a new technique for delivering chemotherapy directly into the lungs at the time of surgery. The goal is to kill any microscopic cancer cells that are present in the lungs at the time of surgery, while sparing other major organs in the body from the side effects of chemotherapy.

Eligible Conditions

Soft Tissue Sarcoma
Bone Sarcoma
Lung Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Phase 1

Similar Trials

Radiotherapy

Pembrolizumab

IVLP in single lung

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Up to 2 years

Up to 2 years

Maximal tolerated dose by using a titration design

Safety of IVLP at selected dose levels by acute lung injury findings

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

Radiotherapy

Pembrolizumab

IVLP in single lung

Side Effects for

Arm A (ABVD)

91%Leukocytes decreased

90%Anemia

82%Neutrophils decreased

77%Fatigue

77%Lymphopenia

76%Nausea

69%Alopecia

47%Neuropathy-sensory

47%Constipation

46%Hyperglycemia

46%Vomiting

45%Hypoalbuminemia

38%Alkaline phosphatase increased

33%Stomatitis

32%Myalgia

29%Platelets decreased

28%Aspartate aminotransferase increased

28%Cough

27%Dyspnea

20%Infection w/o neutropenia

20%Anorexia

19%Bone pain

18%Diarrhea w/o prior colostomy

17%Headache

16%Dyspepsia

16%Insomnia

15%Fever

13%Taste disturbance

13%Injection site reaction

12%Dysphagia

12%Abdominal pain

12%Hypoglycemia

11%Rash/desquamation

11%Arthralgia

10%Sweating

8%Dizziness/lightheadedness

8%Pain-other

8%Chest pain

8%Weight gain

8%Neuropathy-motor

8%Depression

8%Anxiety/agitation

7%Nail changes

7%Edema

7%Rigors/chills

7%Hot flashes

7%Pneumonitis/pulmonary infiltrates

6%Allergic rhinitis

6%Phlebitis

6%Pruritus

6%Blood bilirubin increased

6%Infection w/ grade 3 or 4 neutropenia

6%Creatinine increased

5%Weight loss

4%Radiation dermatitis

4%Dysphagia-esophageal radiation

3%Thrombosis/embolism

2%Mouth dryness

2%Febrile neutropenia

2%Muscle weakness

1%Dehydration

1%Hypoxia

1%Syncope

1%(DLCO) decreased

1%Neuropathic pain

1%Transfusion: pRBCs

1%Cardiac-ischemia

1%Hypothyroidism

This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT00003389) in the Arm A (ABVD) ARM group. Side effects include: Leukocytes decreased with 91%, Anemia with 90%, Neutrophils decreased with 82%, Fatigue with 77%, Lymphopenia with 77%.

Awards & Highlights

No Placebo Group

All patients enrolled in this trial will receive the new treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

9 Treatment Groups

Doxorubicin 7 mcg/ml - expansion

1 of 9

Doxorubicin 13 mcg/ml

1 of 9

Doxorubicin 11 mcg/ml

1 of 9

Doxorubicin 17 mcg/ml

1 of 9

Doxorubicin 20 mcg/ml

1 of 9

Doxorubicin 9 mcg/ml

1 of 9

Doxorubicin 5 mcg/ml

1 of 9

Doxorubicin 7 mcg/ml

1 of 9

Doxorubicin 15 mcg/ml

1 of 9

Experimental Treatment

17 Total Participants · 9 Treatment Groups

Primary Treatment: Doxorubicin · No Placebo Group · Phase 1

Doxorubicin 7 mcg/ml - expansion

Drug