Status:
COMPLETED
Ridaforolimus in Treating Patients With Recurrent Metastatic and/or Locally Advanced Endometrial Cancer
Lead Sponsor:
NCIC Clinical Trials Group
Collaborating Sponsors:
Ariad Pharmaceuticals
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Ridaforolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying th...
Detailed Description
OBJECTIVES: * To assess the efficacy, in terms of objective response rate, of ridaforolimus, in patients with recurrent metastatic and/or locally advanced endometrial cancer. * To assess the adverse ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed endometrial cancer, including any 1 of the following subtypes:
- Adenocarcinoma
- Papillary serous
- Papillary
- Villoglandular
- Mucinous
- Clear cell
- Endometrioid
- Adenosquamous carcinoma
- Recurrent or metastatic and/or locally advanced disease
- Incurable disease by standard therapies
- Clinically and/or radiologically documented disease within the past 28 days (35 days if negative), defined as ≥ 1 unidimensionally measurable disease site meeting 1 of the following criteria:
- At least 20 mm by x-ray or physical exam
- At least 10 mm by spiral CT scan
- At least 20 mm by non-spiral CT scan
- Available tumor tissue (paraffin block or unstained slides) from primary tumor
- No uterine sarcoma (leiomyosarcoma), mixed müllerian tumor (MMT), and/or adenosarcoma
- No known brain metastases
- Clinical suspicion of CNS involvement requires a head CT scan
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- Granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ upper limit of normal (ULN)
- ALT and AST ≤ 2.5 times ULN
- Creatinine ≤ 1.25 times ULN OR creatinine clearance ≥ 50 mL/min
- Fasting serum cholesterol ≤ 9.0 mmol/L
- Fasting triglycerides ≤ 4.56 mmol/L
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Accessible for treatment and follow up (e.g., 1 ½ hours driving distance from participating center)
- No upper gastrointestinal or other condition that would impair swallowing or absorption of oral medication
- No serious illness or medical condition that would not permit the patient to be managed according to the protocol, including, but not limited to, any of the following:
- History of significant neurologic or psychiatric disorder (e.g., uncontrolled psychotic disorders) that would impair the ability to obtain consent or limit compliance with study requirements
- Active uncontrolled or serious infection
- Active peptic ulcer disease
- Myocardial infarction within the past 6 months, congestive heart failure (even if medically controlled), unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, or uncontrolled hypertension
- Pulmonary disease requiring oxygen
- HIV infection or other immune deficiency
- Other medical conditions that might be aggravated by study treatment
- No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
- No known hypersensitivity to the study drug or its components
- PRIOR CONCURRENT THERAPY:
- At least 7 days since prior hormonal therapy (progestational or aromatase inhibitor) as either adjuvant therapy or for treatment of metastatic disease
- At least 21 days since prior major surgery and recovered
- At least 28 days since prior radiotherapy and recovered
- Prior low-dose palliative radiotherapy allowed
- At least 4 months since prior adjuvant chemotherapy
- No prior mTOR inhibitors
- No prior or concurrent chemotherapy for metastatic or recurrent disease
- More than 7 days since prior and no concurrent CYP3A4 inhibitors including, but not limited to, any of the following:
- Azole antifungals (i.e., ketoconazole, itraconazole, miconazole, fluconazole)
- HIV protease inhibitors (i.e., indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
- Clarithromycin
- Verapamil
- Erythromycin
- Delavirdine
- Diltiazem
- Nefazodone
- Telithromycin
- More than 12 days since prior and no concurrent CYP3A4 inducers including, but not limited to, any of the following:
- Rifampin
- Phenytoin
- Rifabutin
- St. John's wort
- Carbamazepine
- Efavirenz
- Phenobarbital
- Tipranavir
- At least 14 days since prior and no concurrent investigational drugs or anticancer therapy (e.g., immunotherapy, biological response modifiers \[excluding hematopoietic growth factors\], and systemic hormonal therapy)
- No concurrent CYP3A4 substrates
Exclusion
Key Trial Info
Start Date :
November 13 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2015
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00770185
Start Date
November 13 2008
End Date
February 13 2015
Last Update
August 4 2023
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
3
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
4
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2