Know Cancer

forgot password

A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients With Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix

Phase 2
18 Years
Open (Enrolling)
Cervical Cancer

Thank you

Trial Information

A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients With Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix


- To assess the efficacy of temsirolimus, in terms of objective response rate, in
patients with unresectable, locally advanced or metastatic carcinoma of the cervix.

- To assess the time to progression and response duration in patients treated with this

- To assess the adverse events associated with this drug in these patients.

- To explore the relationship between expression of proteins in the mTOR pathway in
archival tissue samples and objective response to therapy.

OUTLINE: This is a multicenter study.

Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats
every 28 days for up to 12 courses in the absence of disease progression or unacceptable

Patients undergo tumor tissue sample collection for laboratory biomarker studies, including
analysis of PTEN expression by IHC, PTEN promoter methylation, and PTEN genomic losses and
PIK3CA copy number by FISH.

After completion of study therapy, patients are followed up at 4 weeks and then every 3
months thereafter until relapse/progression.

Inclusion Criteria


- Histologically or cytologically confirmed carcinoma of the cervix, including the
following subtypes:

- Squamous cell carcinoma

- Adenosquamous cell carcinoma

- Adenocarcinoma

- Unresectable, locally advanced or metastatic disease incurable by standard therapy

- Tissue from primary tumor available

- Clinically and/or radiologically measurable disease, as defined by any of the

- At least 20 mm lesion by chest x-ray

- At least 10 mm lesion (in longest diameter) by CT scan (with slice thickness of
< 5 mm)

- At least 10 mm lesion by physical exam (using calipers)

- At least 15 mm lymph nodes by CT scan (measured in short axis)

- No known brain metastases


- ECOG performance status 0-2

- Life expectancy ≥ 12 weeks

- Granulocyte count ≥ 1.5 x 10^9/L

- Platelet count ≥ 100 x 10^9/L

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

- Serum creatinine ≤ 1.5 times ULN

- Fasting serum cholesterol ≤ 9.0 mmol/L

- Fasting triglycerides ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancies except adequately treated nonmelanoma skin cancer or other
solid tumor curatively treated with no evidence of disease for > 5 years

- No serious cardiovascular illness, including any of the following:

- Myocardial infarction within the past 6 months

- Congestive heart failure (even if medically controlled)

- Unstable angina

- Active cardiomyopathy

- Unstable ventricular arrhythmia

- Uncontrolled hypertension

- No serious illness or medical condition that would preclude study participation
including, but not limited to, the following:

- Active uncontrolled infection or non-healing wound

- Active peptic ulcer disease, gastrointestinal perforation, or abscess

- Active bleeding or other medical condition that may be aggravated by study

- History of fistula at any location

- Patients believed to be at high risk for fistula formation because of the
location and extent of their disease should not be enrolled on study

- History of significant neurologic or psychiatric disorder that would impair the
ability to obtain informed consent or limit compliance with study requirements

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to temsirolimus


- No prior treatment with an mTOR inhibitor

- No more than one prior chemotherapy regimen

- Radiosensitizing cisplatin given concurrently with radiotherapy at the time of
initial diagnosis and treatment is not considered systemic chemotherapy

- At least 28 days since prior chemotherapy

- At least 28 days since prior radiotherapy (except for low-dose, palliative
radiotherapy) and recovered

- At least 28 days since prior major surgery (wound healing must have occurred)

- No other concurrent investigational agents or anticancer therapy

- Concurrent therapeutic anticoagulation allowed provided PT/INR or PTT is closely
monitored during study therapy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response as assessed by RECIST criteria

Outcome Time Frame:

after completion of therapy

Safety Issue:


Principal Investigator

Anna Tinker, MD

Investigator Role:

Study Chair

Investigator Affiliation:

British Columbia Cancer Agency


Canada: Health Canada

Study ID:




Start Date:

December 2009

Completion Date:

August 2012

Related Keywords:

  • Cervical Cancer
  • cervical squamous cell carcinoma
  • cervical adenosquamous cell carcinoma
  • cervical adenocarcinoma
  • recurrent cervical cancer
  • stage III cervical cancer
  • stage IVA cervical cancer
  • stage IVB cervical cancer
  • Uterine Cervical Neoplasms