Clinical trial · Interventional
Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
Phase II Study of AZD2171 (NSC#732208) in Patients With Malignant Mesothelioma
NCT00309946CI-TRIAL-00015273completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial is studying how well cediranib maleate works in treating patients with malignant mesothelioma that cannot be removed by surgery. Cediranib maleate 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
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Epithelial Mesothelioma | Epithelioid Mesothelioma | ALIAS | 0.90 |
| Localized Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Recurrent Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Sarcomatous Mesothelioma | Pleural Solitary Fibrous Tumor | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cediranib maleate | Drug | Cediranib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (enzyme inhibitor therapy)
- description
- Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
- interventionNames
- Drug: cediranib maleate
Primary outcomes (1)
- measure
- Objective Response Rate, Complete (CR) or Partial (PR) Response
- timeFrame
- Every 8 weeks
- description
- Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed malignant pleural, peritoneal, or tunica vaginalis mesothelioma * Epithelial, sarcomatoid, or mixed subtype * International Mesothelioma Interest Group stage II-IV disease (for patients with pleural mesothelioma) * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR \> 10 mm by spiral CT scan * Pleural effusion and ascites are not considered measurable lesions * Disease not amenable to curative surgery * No known brain metastases * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100% * Life expectancy \> 3 months * White blood cell (WBC) ≥ 3,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Hemoglobin ≥ 8 g/dL * Platelets ≥ 100,000/mm³ * Total bilirubin normal * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal(ULN) * Creatinine normal OR creatinine clearance \> 60 mL/min * Fertile patients must use effective contraception * Not pregnant or nursing * Negative pregnancy test * No history of allergic reactions to compounds of similar chemical or biologic composition to AZD2171 * Mean corrected QT interval (QTc) ≤ 500 msec (with Bazett's correction) by EKG * No history of long QT syndrome * Proteinuria ≤ 1+ on two consecutive dipsticks taken ≥ 1 week apart * No other concurrent malignancy * No New York Heart Association class III or IV cardiac disease * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Hypertension * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situations that would limit study compliance * No more than 1 prior cytotoxic chemotherapy * Prior intrapleural cytotoxic agents (including bleomycin) do not count towards prior cytotoxic chemotherapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered * No prior radiotherapy to the only site of measurable disease * At least 4 weeks since prior radiotherapy and recovered * At least 4 weeks since prior major surgery and recovered * More than 30 days since prior participation in an investigational trial * No prior treatment with a vascular endothelial growth factor (VEGF) inhibitor * No other concurrent investigational agents * No concurrent commercial agents for the malignancy * No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, or pentamidine) * No concurrent hematopoietic growth factors except epoetin alfa * No concurrent palliative radiotherapy * No combination antiretroviral therapy for HIV-positive patients * No concurrent drugs or biologics with proarrhythmic potential
References
Publications (1)
- RESULTCampbell NP, Kunnavakkam R, Leighl N, Vincent MD, Gandara DR, Koczywas M, Gitlitz BJ, Agamah E, Thomas SP, Stadler WM, Vokes EE, Kindler HL. Cediranib in patients with malignant mesothelioma: a phase II trial of the University of Chicago Phase II Consortium. Lung Cancer. 2012 Oct;78(1):76-80. doi: 10.1016/j.lungcan.2012.06.011. Epub 2012 Jul 23. PMID 22831987