Temsirolimus in Treating Patients With Cervical Cancer That Is Recurrent, Locally Advanced, Metastatic, or Cannot Be Removed By Surgery

NCT01026792 | Completed Phase 2 Results DMC

• 6 other identifiers: NCI-2014-00268NCIC-CTG-199CDR0000660702IND.199CAN-NCIC-IND199NCIC-199
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies the effects of temsirolimus in treating patients with cervical cancer that cannot be cured by standard therapy. Temsirolimus interferes with a protein in cells that is part of one pathway that sends signals to stimulate cell growth and survival. By blocking this protein cancer cells may stop growing or die.

Conditions

Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma; Recurrent Cervical Carcinoma; Stage IIIA Cervical Cancer; Stage IIIB Cervical Cancer; Stage IVA Cervical Cancer; Stage IVB Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Response is defined as a 30% decrease in the sum of the longest diameters of the target lesions (PR) or complete disappearance of disease and symptoms (CR) for at least 4 weeks as assessed by Response Evaluation Criteria in Solid Tumors 1.1

  Up to 3 years

Study Arms (1)

Treatment (temsirolimus)

EXPERIMENTAL

Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses 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, Torisel

Treatment (temsirolimus)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (temsirolimus)

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed squamous cell carcinoma or adenosquamous carcinoma of the cervix, or adenocarcinoma of the cervix
• Patients must have unresectable, locally advanced or metastatic disease, incurable by standard therapies
• Patients must have tumor tissue from their primary tumor available
• Presence of clinically and/or radiologically documented disease
• Chest x-ray \>= 20 mm
• Computed tomography (CT) scan (with slice thickness of =\< 5 mm) \>= 10 mm: longest diameter
• Physical exam (using calipers) \>= 10 mm
• Lymph nodes by CT scan \>= 15 mm: measured in short axis
• All radiology studies must be performed within 21 days prior to registration (within 28 days if negative)
• Patients must have a life expectancy of at least 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• Patients may have had up to one prior chemotherapy regimen; a minimum of 28 days (4 weeks) must have elapsed between the end of chemotherapy and study registration; Note: Radiotherapy with concurrent radiosensitizing cisplatin at the time of initial diagnosis and treatment is permitted, and is not considered systemic chemotherapy
• Patients may have had prior radiation therapy; a minimum of 28 days must have elapsed between the end of radiotherapy and registration onto the study; (exceptions may be made however, for low dose, palliative radiotherapy); patients must have recovered from any acute toxic effects from radiation prior to registration
• Previous major surgery is permitted provided that it has been at least 28 days prior to patient registration and that wound healing has occurred
• Granulocytes (AGC) \>= 1.5 x 10\^9/L

You may not qualify if:

• Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for \>= 5 years
• Patients must not have had prior treatment with an mTOR inhibitor
• Pregnant or lactating women; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with temsirolimus; if the patient is of childbearing potential, a urine beta (β)-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 brain CT is not necessary to rule out brain metastases, unless there is clinical suspicion of CNS involvement); patients with known brain metastases will be excluded from this trial
• 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
• Patients who require use of therapeutic anticoagulation are ELIGIBLE but must have their prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) monitored closely during therapy
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to temsirolimus
• 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 or non-healing wounds
• Active peptic ulcer disease
• Active bleeding or any other medical conditions that might be aggravated by treatment
• Symptomatic congestive heart failure, unstable angina, cardiac arrhythmia
• Fistula or history of fistula at any location, gastrointestinal (GI) perforation or abscess; patients believed to be at high risk for fistula formation because of the location and extent of their disease should not be enrolled

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

Uterine Cervical Neoplasms

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Anna Tinker
• Organization: BC Cancer Agency, Vancouver Clinic, Vancouver, BC, Canada

atinker@bccancer.bc.ca

604 877 6217

Study Officials

• Anna Tinker

  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: December 3, 2009
• First Posted: December 4, 2009
• Study Start: December 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 10, 2015
• Results First Posted: September 10, 2015

Record last verified: 2014-02

Locations

CA (1)