Cediranib as Palliative Treatment in Patients With Symptomatic Malignant Ascites or Pleural Effusion

NCT01262612 | Terminated Phase 2 DMC

• 1 other identifier: UMCNONCO201001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

In some patients with cancer there are also cancer cells in the abdominal cavity or between the lung membranes. These cancer cells create too much moisture in the abdominal cavity or between the lung membranes. If there is fluid in the abdominal cavity (ascites fluid) this can bring on abdominal distension, abdominal pain, loss of appetite, fatigue, bloating and sometimes wheezing. Too much fluid between the lung membranes (we call this pleural fluid) gives breathlessness, chest pain and coughing. The use of diuretics may offer a small group of patients symptom reduction. Additionally, the fluid can be drained through a needle puncture or fluid collection (through a biopsy). But usually, the moisture quickly returns. Previous research done in this hospital with cediranib showed that with some patients with cancer who suffered from fluid in the abdominal cavity or between the lung membranes, this moisture reduces while using this drug. It also reduced the symptoms caused by this excessive moisture. The current study is conducted to see whether patients with cancer and fluid in the abdominal cavity or fluid between the lung blades benefit from using cediranib. This involves not only whether the amount moisture reduces, but also if the complains decrease. In addition, we will carefully consider the possible side effects of cediranib.

Conditions

Malignant Ascites; Malignant Pleural Effusion

Keywords

cediranib; malignant ascites; malignant pleural effusion

Outcome Measures

Primary Outcomes (1)

• puncture free survival

  If the puncture free survival after start of treatment with cediranib (time to first need for paracentesis or thoracentesis or time to death, which event occurred first) is more than 44 days the treatment of ascites and/or pleural effusion with cediranib is effective.

  44 days

Study Arms (2)

immediate treatment with cediranib

ACTIVE COMPARATOR

8 patients with ascites and 8 patients with pleural effusion will start immediate treatment with cediranib

Drug: immediate cediranib

start cediranib after 28 days BSC

ACTIVE COMPARATOR

patients in group B will start with cediranib after one month best supportive care.

Drug: Start cediranib after 28 days Best Supportive Care

Interventions

immediate cediranib DRUG

cediranib 30 mg on day one; Special in this study is the possibility to decrease (to a minimum of 15 mg) or increase the dose (to a maximum of 30 mg oid) during the study to get an individualized optimal palliative treatment with cediranib. The patient will continue cediranib as long as a clinical benefit is experienced, independent of tumour evaluation. Each dose changes should be documented with clear reasoning and documentation of the approach taken

Also known as: AZD2171

immediate treatment with cediranib

Start cediranib after 28 days Best Supportive Care DRUG

patients in this group will start with cediranib after one month best supportive care. Special in this study is the possibility to decrease (to a minimum of 15 mg) or increase the dose (to a maximum of 30 mg oid) during the study to get an individualized optimal palliative treatment with cediranib. The patient will continue cediranib as long as a clinical benefit is experienced, independent of tumour evaluation. Each dose changes should be documented with clear reasoning and documentation of the approach taken.

Also known as: AZD2171

start cediranib after 28 days BSC

Eligibility Criteria

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

You may qualify if:

• Symptomatic malignant ascites and/or pleural effusion (from a histological proven solid malignancy which is refractory to standard anti-tumour therapy of for which no standard therapy exists)
• Karnofsky score ≥ 50 if the low performance score is due to ascites and/or pleural effusion, otherwise ≥ 60
• Age ≥ 18 years
• Written informed consent

You may not qualify if:

• Contraindications for treatment with cediranib:
• The presence of a pleural or peritoneal tap
• Untreated unstable brain or meningeal metastases.
• Previous treatment with chemotherapeutic agents or tyrosine kinase inhibitors (TKIs) within 14 days prior to the first dose of cediranib, with cetuximab within 30 days prior to the first dose of cediranib, or with bevacizumab within 60 days prior to the first dose of cediranib
• Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count ≤1.5 x 109/L or platelet count ≤100 x 109/L
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2,5 x ULN
• Serum creatinine \> 1.5 x ULRR or a creatinine clearance of ≤ 50mL/min calculated by Cockcroft-Gault
• Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart unless urinary protein \< 1.5g in a 24 hr period
• Prothrombin time (PT) and activated partial thromboplastin time (APTT) \> 2 x ULN History of significant gastrointestinal impairment, as judged by the Investigator, that would significantly affect the absorption of cediranib, including the ability to swallow the tablet whole. Patients with an ileostoma.
• Patients with a history of poorly controlled hypertension with resting blood pressure \>150/100 in the presence or absence of a stable regimen of anti-hypertensive therapy. Patients who are currently receiving maximal doses of calcium channel blockers or more than 1 antihypertensive for the treatment of hypertension are also ineligible.
• Any evidence of severe or uncontrolled diseases e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease.
• Unresolved toxicity \> CTC grade 1 from previous anti-cancer therapy (including radiotherapy) except alopecia (if applicable) or polyneuropathy.
• Mean QTc with Bazetts correction \>470msec in screening ECG or history of familial long QT syndrome
• Significant haemorrhage (\>30mL bleeding/episode in previous 3 months) or haemoptysis (\>5mL fresh blood in previous 4 weeks)
• Recent (\<14 days) major surgery prior to entry into the study, or a surgical incision that is not fully healed

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

University Medical Centre Nijmegen

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

cediranib

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• C.M.L. van Herpen, Md PhD

  University Medical Centre Nijmegen

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

NL (1)