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Phase 2 Completed N=38 Treatment

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

Source: ClinicalTrials.gov NCT01026792 ↗
Enrolled (actual)
38
Serious AEs
40.5%
Results posted
Sep 2015
Primary outcomePrimary: Objective Response Rate — 3 percentage of patients with response

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Objective Response Rate
3

Eligibility Criteria

Inclusion Criteria

  • 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 = = 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
  • Platelets >= 100 x 10^9/L
  • Serum creatinine = = 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 o
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01026792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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