Study of the mTOR Inhibitor Temsirolimus (CCI-779) to Treat Ovarian Cancer With CA125 Only Relapse

NCT00926107 | Terminated Phase 2

• 2 other identifiers: HE 4/092008-007925-38
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 12

Brief Summary

The primary objective of this study is to determine the efficacy of Temsirolimus in patients with ovarian cancer with CA125 only relapse after first-line platinum-based chemotherapy.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical progression free survival.

  6-month

Secondary Outcomes (1)

• Progression Free Survival (PFS),Survival, CA125 response rate, Safety

  Duration of the study

Interventions

Temsirolimus DRUG

Temsirolimus 25mg weekly until clinical progression

Eligibility Criteria

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

You may qualify if:

• Histologic proof of epithelial ovarian,fallopian or peritoneal carcinoma of the following histological types:serous, endometrioid, mucinous, clear cell, low differentiation.
• Age 18 years or older
• Patients should have received first-line platinum based chemotherapy
• Documented CA125 progression according to GCIC criteria.
• No evidence of measurable or evaluable disease.
• Provision of written informed consent
• ECOG PS 0-2
• Life expectancy of greater than 12 weeks
• WBC\>4000/μl, platelets \> 100,000/μl and a hemoglobin level \> 9.5 g/dl. Adequate baseline hepatic function, defined as a total bilirubin level \< 2 mg/dl, SGPT and SGOT \< 2.5 times the upper limits of normal. Creatinine \< 1.5 mg/dl or creatinine clearance \> 60 ml/min.
• All females of childbearing potential must have a negative serum or urine pregnancy test obtained within 2 days prior to initiation of treatment and use effective contraception during the period of therapy.
• At least one month from the last chemotherapy administration.
• Provision of adequate paraffin-embedded tumor tissue for translational studies (optional).

You may not qualify if:

• Other histological types (germ cell, granulose tumors etc)
• History of atrial or ventricular arrhythmias and/or history of congestive heart failure, even if medically controlled. History of clinical and electrocardiographically documented myocardial infarction within the last 6 months from study entry
• Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
• Pre-existing motor or sensory neurotoxicity grade 2 according to the WHO criteria (intolerable paresthesia and/or marked motor loss or worse)
• History of any treatment for CA125 relapse
• Known, severe hypersensitivity to temsirolimus or any of the excipients of this product
• Other coexisting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
• As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
• Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR.
• Active infection or evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial/ receive protocol treatment
• Concomitant use of Cyp3 A inducers (phenytoin, carbamazepine, rifampicin, barbiturates or St John's Wort) should be avoided and as should treatment with strong CyP 3A inhibitors
• Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (12)

"Alexandra" Hospital, Dept. of Clinical Therapeutics, Oncology

Athens, 11528, Greece

Location

"Attikon" University Hospital, 2nd Dept. of Internal Medicine-Propaedeutic, Oncology Section

Athens, 12461, Greece

Location

Hygeia Hospital, 1st Dept. of Medical Oncology

Athens, 15123, Greece

Location

Hygeia Hospital, 2nd Dept. of Medical Oncology

Athens, 15123, Greece

Location

Agii Anargiri Cancer Hospital, 3rd Dept. of Medical Oncology

Athens, Greece

Location

Chania General Hospital, Oncology Dept.

Chania, 73100, Greece

Location

Ioannina University Hospital, Dept. of Medical Oncology

Ioannina, 45110, Greece

Location

Larissa University Hospital, Oncology Dept.

Larissa, 41110, Greece

Location

University Hospital of Patras, Oncology Dept

Pátrai, 26500, Greece

Location

Metropolitan Hospital, 1st Dept. of Medical Oncology

Pireaus, 18547, Greece

Location

Metropolitan Hospital, 2nd Dept. of Medical Oncology

Pireaus, 18547, Greece

Location

"Papageorgiou" General Hospital, Dept. of Medical Oncology

Thessaloniki, 56429, Greece

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

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

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 23, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 10, 2011

Record last verified: 2011-11

Locations

GR (12)