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A Phase II Trial of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma

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Trial Conditions
  • Malignant Mesothelioma
What is the purpose of this trial?

RATIONALE: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is study how well AZD2171 works in treating patients with malignant pleural mesothelioma that cannot be removed by surgery.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically confirmed epithelial, sarcomatous, or biphasic malignant pleural
mesothelioma

- Unresectable disease

- Residual disease after prior cytoreductive surgery allowed

- Measurable disease by CT scan or MRI

- Prior treatment with platinum-based chemotherapy required

- No known CNS metastasis

PATIENT CHARACTERISTICS:

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- AST or ALT ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin normal

Renal

- Creatinine ≤ 1.5 times ULN OR

- Creatinine clearance ≥ 50 mL/min

- Proteinuria ≤ 1+ by 2 consecutive dipstick tests taken ≥ 1 week apart

Cardiovascular

- No history of familial long QT syndrome

- Mean QTc ≤ 470 msec

- Systolic BP ≤ 150 mm Hg AND diastolic BP ≤ 100 mm Hg

- Must have New York Heart Association class I or II disease

- Class II must be controlled with treatment

Gastrointestinal

- Able to swallow and/or receive enteral medications via gastrostomy feeding tube

- Not requiring IV alimentation

- No active peptic ulcer

- No intractable nausea or vomiting

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer in remission

- No history of hypersensitivity reaction to compounds of similar chemical or
biological composition to the study drug

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Prior monoclonal antibody therapy targeting vascular endothelial growth factor
(VEGF), VEGF receptor 1 (VEGFR1) or VEGF receptor 2 (VEGFR2) allowed

- No other prior immunotherapy or biologic therapy

- No prior thymidine kinase inhibitor against VEGFR1 or VEGFR2

- No concurrent drugs or biologics with proarrythmic potential

Chemotherapy

- See Disease Characteristics

- No more than 1 prior chemotherapy regimen

- At least 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin) and
recovered

Radiotherapy

- At least 21 days since prior radiotherapy and recovered

Surgery

- See Disease Characteristics

- At least 28 days since prior major surgery (e.g., thoracotomy or laparotomy) and
recovered

- No prior surgery that would affect absorption

Other

- Stable antihypertensive therapy allowed provided blood pressure (BP) parameters are
met

- Concurrent enrollment on SWOG-S9925 allowed

- No concurrent combination antiretroviral therapy for HIV-positive patients

Gender: Both
Steward Physician(s)
  • Linda Garland, MD
  • Antoinette J. Wozniak, MD
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Drug
  • cediranib maleate
Physician Researcher

Investigator Name:

  • Linda Garland, MD
  • Antoinette J. Wozniak, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 2
Trial ID: NCT00243074
Volunteers:  Not Accepting Healthy Volunteers

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