Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well temsirolimus works in treating patients with locally advanced or metastatic cervical cancer that cannot be removed by surgery.

Further Study Information

OBJECTIVES:

• 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 drug.

• 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 toxicity.

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• 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 following:

• 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

PATIENT CHARACTERISTICS:

• 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 treatment

• 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

PRIOR CONCURRENT THERAPY:

• 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

Trial Contact Information

Trial Lead Organizations/Sponsors

NCIC-Clinical Trials Group

Anna Tinker

Study Chair

Helen MacKay, M.D

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01026792
Information obtained from ClinicalTrials.gov on December 14, 2011

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