Temsirolimus in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer

NCT00072176 | Completed Phase 2 Results

• 6 other identifiers: NCI-2014-00649I160CAN-NCIC-IND160IND.160CDR0000335543NCIC-160
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well temsirolimus works in treating patients with endometrial cancer that has spread to other parts of the body or has spread from where it started to nearby tissue or lymph nodes and has come back after a period of time during which the cancer could not be detected. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Endometrial Adenocarcinoma; Endometrial Adenosquamous Cell Carcinoma; Endometrial Clear Cell Carcinoma; Endometrial Papillary Serous Carcinoma; Recurrent Endometrial Carcinoma; Stage IIIA Endometrial Carcinoma; Stage IIIB Endometrial Carcinoma; Stage IIIC Endometrial Carcinoma; Stage IVA Endometrial Carcinoma; Stage IVB Endometrial Carcinoma

Outcome Measures

Primary Outcomes (2)

• Objective Clinical Response Rate

  Defined as proportion of patients with 30% decrease in the sum of the longest diameters of the target lesions (partial response) maintained for at least 4 weeks, or complete disappearance of disease and cancer related symptoms (complete response) and confirmed on independent radiology review.

  Up to 5 years

• Progression-free Survival (Tumor Progression)

  Time to tumor progression or death

  5 years

Study Arms (1)

Treatment (temsirolimus)

EXPERIMENTAL

Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: temsirolimus; Other: laboratory biomarker analysis

Interventions

temsirolimus DRUG

Given IV

Also known as: CCI-779, cell cycle inhibitor 779, Torisel

Treatment (temsirolimus)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (temsirolimus)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed metastatic and/or locally advanced recurrent adenocarcinoma (papillary serous, papillary, villoglandular, mucinous, clear cell), endometrioid or adenosquamous carcinoma of the endometrium, incurable by standard therapies
• Patients must have tumour tissue from their primary tumor available to assess molecular markers of CCI-779 activation (paraffin block or unstained slides)
• Presence of clinically and/or radiologically documented disease; at least one site of disease must be unidimensionally measurable as follows:
• X-ray, physical exam \>= 20 mm
• Spiral computed tomography (CT) scan \>= 10 mm
• Non-spiral CT scan \>= 20 mm
• All radiology studies must be performed within 28 days prior to registration (within 35 days if negative)
• Patients must have a life expectancy of at least 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
• Previous therapy:
• Hormonal therapy:
• Group A: One prior hormonal treatment (progestational or aromatase inhibitor) as either adjuvant therapy or for treatment of metastatic disease
• Group B: No limit to number of prior hormonal treatments given (progestational or aromatase inhibitor) as either adjuvant therapy or for treatment of metastatic disease
• Time since last hormone: \>= 1 week since last dose of hormonal therapy (applies to both Groups)
• Chemotherapy:

You may not qualify if:

• Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \>= 5 years
• Patients must not have had prior treatment with an mammalian target of rapamycin (mTOR) inhibitor
• Uterine sarcomas (leiomyosarcoma), mixed mullerian tumours (MMT) and/or adenosarcomas
• Patients with non-measurable disease only; (please note that bone metastases are considered non-measurable)
• Pregnant or lactating women; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with CCI-779; most patients enrolled on this trial will have had a prior hysterectomy or pelvic irradiation; however, if the patient is of childbearing potential, a urine beta-human chorionic gonadotropin (HCG) must be proved negative within 7 days prior to registration; women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Patients with known brain metastases; (a head CT is not necessary to rule out brain metastases, unless there is clinical suspicion of central nervous system \[CNS\] involvement)
• Patients with serious cardiovascular illness such as myocardial infarction within 6 months prior to entry, congestive heart failure (even if medically controlled), unstable angina, active cardiomyopathy, unstable ventricular arrhythmia or uncontrolled hypertension
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779
• Patients receiving concurrent treatment with other anti-cancer therapy or other investigational agents
• Serious illness or medical condition which would not permit the patient to be managed according to the protocol including, but not limited to:
• History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements
• Active uncontrolled infection
• Active peptic ulcer disease
• Any other medical conditions that might be aggravated by treatment

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute of Canada Clinical Trials Group

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

temsirolimus; Sirolimus

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Dr. Amit M. Oza
• Organization: Princess Margaret Hospital, Toronto, Canada

amit.oza@uhn.ca

416 946 4501

Study Officials

• Amit Oza

  Canadian Cancer Trials Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 6, 2003
• Study Start: May 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: August 1, 2009
• Last Updated: February 23, 2015
• Results First Posted: February 23, 2015

Record last verified: 2014-03

Locations

CA (1)