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A Phase I/IB Study fo AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies

Phase 1
18 Years
Open (Enrolling)
Endometrial Cancer, Ovarian Cancer, Cervical Cancer, Fallopian Cancer, Peritoneal Cancer

Thank you

Trial Information

A Phase I/IB Study fo AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies

- 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.

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

- 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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose of cediranib with temsirolimus in patients with recurrent/refractory gynecological malignancies.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Susana Campos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2010

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Ovarian Cancer
  • Cervical Cancer
  • Fallopian Cancer
  • Peritoneal Cancer
  • AZD2171
  • temsirolimus
  • advanced gynecological malignancies
  • Neoplasms
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Adenoma



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617