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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.

    Page 1 of 3 (11 locations)

    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