AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies

NCT01065662

Last updated date
Study Location
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Endometrial Cancer, Ovarian Cancer, Cervical Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with metastatic endometrial cancer

- Patients with recurrent ovarian, fallopian and peritoneal cancer

- Patients with recurrent cervical cancer

- Patients may have either measurable or non-measurable disease

- Up to one prior line of chemotherapy in the recurrent setting is allowed. Biologic therapies will be considered as a prior line but hormonal therapies do not count.

- No prior VEGF inhibitor therapy allowed.

- Toxic side effects related to prior chemotherapy or hormonal therapy must have resolved to less than or equal to grade 1 or to baseline (excluding alopecia), or for peripheral neuropathy to less than or equal to grade 2.

- Subjects may begin AZD2171 and temsirolimus at least 3 weeks after their last dose of chemotherapy or hormonal therapy, assuming they are otherwise eligible.

- 18 years of age or older

- At present, the potential of AZD2171 for clinically significant drug interactions involving the CYP isozymes is unknown. Eligibility of patients receiving any medication or substances known to affect or with teh potential to affect the activity or PK of AZD2171 will be determined following review of their case by the principal investigator.

- Subjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible if they otherwise meet eligibility. Subjects with stage I or II cancer treated with curative intent are also eligible with no evidence of recurrent disease.

- No evidence of preexisting uncontrolled hypertension. If patient has hypertension, it must be medically controlled prior to starting AZD2171.

- Women of child-bearing potential must have a negative pregnancy test prior to study entry. Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.

- No therapeutic anticoagulation. The use of low dose warfarin, intermittent doses of TPA, or heparin flushes to prophylaxis against central venous catheter-associated clots is permitted.

- ECOG Performance status 0-2

- Patients must have normal organ and marrow function as defined in the protocol

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients who have had chemotherapy, radiotherapy, or major surgery within 3 weeks (6
weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have
not recovered from adverse events due to agents administered more than 3 weeks
earlier.


- Patients may not be receiving any other investigational agents nor have participated
in an investigational trial within the past 4 weeks. Prior bevacizumab is allowed.


- Patients may not be receiving any medication that may markedly affect renal function.
NSAIDs should be avoided if possible.


- Patients with known brain metastases should be excluded from this clinical trial. A CT
of the head is required prior to entry into the study.


- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to AZD2171.


- Mean QTc of 470msec or greater in screening electrocardiogram or history of familial
long QT syndrome.


- Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week
apart


- Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
myocardial infarction cardiac arrhythmia, or psychiatric illness/social situations
that would limit compliance with study requirements.


- Inability to take and absorb orally administered medication.


- Pregnant women. Breastfeeding should be discontinued.


- Major surgical procedure or medical interference with peritoneum or pleura within 4
weeks of baseline CA-125 assessments. This excludes the need for a paracentesis.


- Subjects with a history of an active malignancy during the last 3 years except
non-melanomatous skin cancer, in situ breast or cervical cancer or stage I or II
cancer treated with a curative intent and no active cancer recurrence.


- HIV-positive patients on combination antiretroviral therapy are ineligible because of
the potential for pharmacokinetic interactions with AZD2171.


- New York Heart Association classification of III or IV


- Conditions requiring concurrent use of drugs or biologics with proarrhythmic
potential.

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Endometrial Cancer, Ovarian Cancer, Cervical Cancer, Fallopian Tube Cancer, Peritoneal CancerAZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies
NCT01065662
  1. Boston, Massachusetts
  2. Boston, Massachusetts
  3. Boston, Massachusetts
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies
Official Title  ICMJE A Phase I/IB Study fo AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies
Brief Summary The purpose of this research study is to determine the safety of the combination of the two drugs cediranib and temsirolimus and the highest doses of these two drugs that can be given in combination to people safely. Cediranib is a drug that may stop blood supply to the tumor and therefore help keep cancer cells from growing. Temsirolimus is a drug that may stop cancer cells from growing. These drugs have been used in other research studies in ovarian and kidney cancer and these studies suggest that these drugs may help to keep cancer from growing in this research study.
Detailed Description
  • We are looking for the highest dose of the study drugs that can be administered safely without severe or unmanageable side effects in participants that have recurrent gynecological cancers. Not everyone who participates in this research study will receive the same dose of the study drug.
  • There will be samples of blood taken that measure any additional effect of the study drugs and to look for a marker for the participant's particular type of cancer. Blood will be taken at a certain point in the study to evaluate the interaction of the two study drugs, cediranib and temsirolimus when given together. These are called pharmacokinetic (PK) samples. About 6 teaspoons of blood will be taken with each PK sample with a total of 34 samples taken.
  • Participants will be given a study medication diary for each treatment cycle. Each cycle lasts four weeks (28 days). Temsirolimus will be given on days 1, 8, 15 and 22 of each cycle. Cediranib wil be taken orally once daily in the morning.
  • Participants will be asked to monitor their blood pressure on a daily basis at home and keep a blood pressure diary.
  • The following tests and procedures will be performed at specific time periods during the course of the study: medical history; side effect assessment; physical exam; vital signs; blood tests; CT scan; MUGA or ECHO; EKG and urine test.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Endometrial Cancer
  • Ovarian Cancer
  • Cervical Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
Intervention  ICMJE
  • Drug: temsirolimus
    Given on days 1, 8, 15 and 22 of each cycle
  • Drug: cediranib
    Taken orally daily
Study Arms  ICMJE Experimental: Cediranib and Temsirolimus
Please see interventions section.
Interventions:
  • Drug: temsirolimus
  • Drug: cediranib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2010)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with metastatic endometrial cancer
  • Patients with recurrent ovarian, fallopian and peritoneal cancer
  • Patients with recurrent cervical cancer
  • Patients may have either measurable or non-measurable disease
  • Up to one prior line of chemotherapy in the recurrent setting is allowed. Biologic therapies will be considered as a prior line but hormonal therapies do not count.
  • No prior VEGF inhibitor therapy allowed.
  • Toxic side effects related to prior chemotherapy or hormonal therapy must have resolved to less than or equal to grade 1 or to baseline (excluding alopecia), or for peripheral neuropathy to less than or equal to grade 2.
  • Subjects may begin AZD2171 and temsirolimus at least 3 weeks after their last dose of chemotherapy or hormonal therapy, assuming they are otherwise eligible.
  • 18 years of age or older
  • At present, the potential of AZD2171 for clinically significant drug interactions involving the CYP isozymes is unknown. Eligibility of patients receiving any medication or substances known to affect or with teh potential to affect the activity or PK of AZD2171 will be determined following review of their case by the principal investigator.
  • Subjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible if they otherwise meet eligibility. Subjects with stage I or II cancer treated with curative intent are also eligible with no evidence of recurrent disease.
  • No evidence of preexisting uncontrolled hypertension. If patient has hypertension, it must be medically controlled prior to starting AZD2171.
  • Women of child-bearing potential must have a negative pregnancy test prior to study entry. Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.
  • No therapeutic anticoagulation. The use of low dose warfarin, intermittent doses of TPA, or heparin flushes to prophylaxis against central venous catheter-associated clots is permitted.
  • ECOG Performance status 0-2
  • Patients must have normal organ and marrow function as defined in the protocol

Exclusion Criteria:

  • Patients who have had chemotherapy, radiotherapy, or major surgery within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
  • Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks. Prior bevacizumab is allowed.
  • Patients may not be receiving any medication that may markedly affect renal function. NSAIDs should be avoided if possible.
  • Patients with known brain metastases should be excluded from this clinical trial. A CT of the head is required prior to entry into the study.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171.
  • Mean QTc of 470msec or greater in screening electrocardiogram or history of familial long QT syndrome.
  • Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart
  • Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Inability to take and absorb orally administered medication.
  • Pregnant women. Breastfeeding should be discontinued.
  • Major surgical procedure or medical interference with peritoneum or pleura within 4 weeks of baseline CA-125 assessments. This excludes the need for a paracentesis.
  • Subjects with a history of an active malignancy during the last 3 years except non-melanomatous skin cancer, in situ breast or cervical cancer or stage I or II cancer treated with a curative intent and no active cancer recurrence.
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD2171.
  • New York Heart Association classification of III or IV
  • Conditions requiring concurrent use of drugs or biologics with proarrhythmic potential.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01065662
Other Study ID Numbers  ICMJE 09-397
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susana M. Campos, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Susana M. Campos, MD
Collaborators  ICMJE
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • National Comprehensive Cancer Network
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • AstraZeneca
Investigators  ICMJE
Principal Investigator:Susana Campos, MDDana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP