Study Summary
This trial is studying olaparib and temozolomide to see how well they work in treating patients with uterine leiomyosarcoma.
Eligible Conditions
- Uterine Corpus Leiomyosarcoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: Up to 2 years
Year 2
Progression-free survival (PFS)
Up to 2 years
Proportion of MGMT protein expression in uterine LMS tumors
Proportion of uterine LMS tumors exhibit homologous recombination (HR) deficiency
Schlafen family member number 11(SLFN11) protein expression
Year 2
Incidence of adverse events
Month 6
Confirmed objective response rate (ORR) (complete response + partial response)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
36%Febrile neutropenia
31%Death NOS
30%Diarrhea
22%Pain
21%Hyperglycemia
16%Alanine aminotransferase increased
16%Anorexia
16%Infections and infestations - Other, specify
14%Hypokalemia
13%Nausea
11%Hyponatremia
10%Weight loss
9%Aspartate aminotransferase increased
9%Constipation
9%Dehydration
9%Hypophosphatemia
9%Vomiting
9%Mucositis oral
9%Anemia
8%Platelet count decreased
8%Sepsis
7%Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%Abdominal pain
7%Colitis
7%Catheter related infection
6%Hypoalbuminemia
6%Hypotension
6%GGT increased
6%Hypocalcemia
6%Fever
6%Urinary retention
6%White blood cell decreased
5%Urinary tract infection
5%Typhlitis
5%Anxiety
5%Neutrophil count decreased
4%Epistaxis
4%Enterocolitis
4%Lipase increased
4%Pleural effusion
4%Urinary tract obstruction
4%Peripheral motor neuropathy
4%Skin infection
4%Serum amylase increased
3%Syncope
3%Dermatitis radiation
3%Bone pain
3%Dyspnea
3%Lymphocyte count decreased
3%Wound infection
3%Hematuria
3%Blood bilirubin increased
3%Edema limbs
3%Hypertension
3%Hypercalcemia
3%Sinus tachycardia
2%Abdominal distension
2%Creatinine increased
2%Lung infection
2%Acute kidney injury
2%Apnea
2%Left ventricular systolic dysfunction
2%Pancreatitis
2%Peripheral sensory neuropathy
2%Rectal hemorrhage
2%Thromboembolic event
2%Stridor
2%Back pain
2%Enterocolitis infectious
2%Hyperkalemia
2%Musculoskeletal and connective tissue disorder - Other, specify
2%Investigations - Other, specify
2%Muscle weakness lower limb
2%Tumor pain
2%Proctitis
2%Pain in extremity
2%Urticaria
2%Depressed level of consciousness
2%Vulval infection
2%Allergic reaction
2%Portal hypertension
2%Upper gastrointestinal hemorrhage
2%Stoma site infection
2%Skin ulceration
1%Anaphylaxis
1%Hypoxia
1%Ascites
1%Multi-organ failure
1%Oral pain
1%Confusion
1%Alkaline phosphatase increased
1%Anal ulcer
1%Ejection fraction decreased
1%Fracture
1%Heart failure
1%Esophageal pain
1%Gastric hemorrhage
1%Gum infection
1%Hepatobiliary disorders - Other, specify
1%Hydrocephalus
1%Ileus
1%Oral hemorrhage
1%Rectal fistula
1%Pulmonary edema
1%Penile pain
1%Sore throat
1%Tracheitis
1%Acidosis
1%Vascular disorders - Other, specify
1%Vasovagal reaction
1%Abdominal infection
1%Anal hemorrhage
1%Bladder spasm
1%Anal mucositis
1%Congenital, familial and genetic disorders - Other, specify
1%Chest wall pain
1%Device related infection
1%Hoarseness
1%CPK increased
1%Depression
1%Gastrointestinal disorders - Other, specify
1%Esophagitis
1%Gastric ulcer
1%Laryngeal mucositis
1%Hypoglycemia
1%Myositis
1%Menorrhagia
1%Nail infection
1%Renal and urinary disorders - Other, specify
1%Pharyngitis
1%Pneumonitis
1%Spinal fracture
1%Seizure
1%Small intestine infection
1%Gait disturbance
1%Encephalopathy
1%Generalized muscle weakness
1%Pelvic pain
1%Laryngeal edema
1%Rectal pain
1%Disseminated intravascular coagulation
1%Endocrine disorders - Other, specify
1%Respiratory, thoracic and mediastinal disorders - Other, specify
1%Pleuritic pain
1%Sinusitis
1%Bone marrow hypocellular
1%Appendicitis
1%Esophageal infection
1%Delirium
1%Ear and labyrinth disorders - Other, specify
1%Esophageal stenosis
1%Hypertriglyceridemia
1%INR increased
1%Myelodysplastic syndrome
1%Rash maculo-papular
1%Respiratory failure
1%Anal fistula
1%Lethargy
1%Fall
1%Dizziness
1%Eye disorders - Other, specify
1%Tooth infection
1%Fatigue
1%Headache
1%Skin and subcutaneous tissue disorders - Other, specify
1%Hypernatremia
1%Insomnia
1%Kyphosis
1%Soft tissue infection
1%Hypomagnesemia
1%Irregular menstruation
1%Irritability
1%Joint range of motion decreased cervical spine
1%Pyramidal tract syndrome
1%Pain of skin
1%Pneumothorax
1%Postoperative hemorrhage
1%Pruritus
1%Salivary duct inflammation
1%Tumor lysis syndrome
1%Upper respiratory infection
Trial Design
1 Treatment Group
Treatment (olaparib, temozolomide)
1 of 1
Experimental Treatment
25 Total Participants · 1 Treatment Group
Primary Treatment: Temozolomide · No Placebo Group · Phase 2
Treatment (olaparib, temozolomide)Experimental Group · 5 Interventions: Computed Tomography, Core Biopsy, Magnetic Resonance Imaging, Temozolomide, Olaparib · Intervention Types: Procedure, Procedure, Procedure, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3410
Core Biopsy
2013
N/A
~130
Magnetic Resonance Imaging
2017
Completed Phase 2
~1100
Temozolomide
FDA approved
Olaparib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,070 Previous Clinical Trials
41,128,797 Total Patients Enrolled
11 Trials studying Uterine Corpus Leiomyosarcoma
743 Patients Enrolled for Uterine Corpus Leiomyosarcoma
Matthew InghamPrincipal InvestigatorYale University Cancer Center LAO
3 Previous Clinical Trials
143 Total Patients Enrolled
1 Trials studying Uterine Corpus Leiomyosarcoma
70 Patients Enrolled for Uterine Corpus Leiomyosarcoma
Eligibility Criteria
Age 18+ · Female Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are eligible for this study if you have histologically documented uterine leiomyoma.
Hemoglobin > 9 g/dL (without transfusion of packed red blood cells within the past 28 days) (measured within 14 days prior to administration of study treatment) is a prerequisite for study treatment.
You have locally advanced or metastatic disease.
You have had prior progression on, or intolerance to, at least one line of systemic therapy for advanced LMS
You have absolute neutrophil count > 1,500/mcL.
You have a platelet count of at least 100,000/mcL.
Who else is applying?
What state do they live in?
| Michigan | 100.0% |
How old are they?
| 65+ | 100.0% |
What site did they apply to?
| Weisberg Cancer Treatment Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Vyse, Simon, Khin Thway, Paul H. Huang, and Robin L. Jones. 2021. “Next-generation Sequencing for the Management of Sarcomas with No Known Driver Mutations”. Current Opinion in Oncology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/cco.0000000000000741.
- Vyse S, Thway K, Huang PH, Jones RL. Next-generation sequencing for the management of sarcomas with no known driver mutations. Curr Opin Oncol. 2021 Jul 1;33(4):315-322. doi: 10.1097/CCO.0000000000000741.
- 2019. "A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03880019.
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Conditions
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Treatments