Phase II Study of DMXAA (ASA404) in Combination With Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Antisoma Research
ClinicalTrials.gov Identifier:
NCT00832494
First received: January 29, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

This study was designed to test the addition of DMXAA (now known as ASA404) to carboplatin and paclitaxel in patients with NSCLC.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: DMXAA in combination with carboplatin and paclitaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Phase I/II Study of DMXAA in Combination With Carboplatin and Paclitaxel in Patients With Locally Advanced and Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Antisoma Research:

Primary Outcome Measures:
  • Safety and tolerability of combination
  • Tumor response rate
  • Time to tumor progression
  • Duration of response and stable disease; median and one-year survival

Enrollment: 105
Study Start Date: September 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: DMXAA in combination with carboplatin and paclitaxel
    Administered every 21 days
    Other Name: DMXAA is now known as ASA404
Detailed Description:

The study was designed to determine the safety, tolerability and efficacy of DMXAA in combination with carboplatin and paclitaxel in patients with locally advanced and metastatic (Stage IIIb and IV) non-small cell lung cancer. The phase Ib part of the study evaluated dose levels of DMXAA at 600 mg/m2, 1200 mg/m2 and 1800 mg/m2. In the phase II part of the study, patients were randomized to receive carboplatin and paclitaxel alone or in combination with ASA404 1200 mg/m2. An additional single-arm study was undertaken to evaluate further patients at the 1800 mg/m2 dose level.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  1. Histologically confirmed non-small cell lung carcinoma designated as adenocarcinoma (including bronchoalveolar), squamous cell carcinoma or undifferentiated, mixed (adenocarcinoma and squamous) or large cell carcinoma.
  2. Locally advanced Stage IIIb disease, not curable with surgery or radiotherapy, or Stage IV disease.
  3. Aged ≥ 18 years of age.
  4. Karnofsky performance status of ≥ 70%.
  5. Life expectancy of ≥ 3 months.
  6. Hematological and biochemical indices at screening comprising:

    • An absolute neutrophil count of ≥ 2.0 x 109/L.
    • A platelet count of ≥ 100 x 109/L.
    • A hemoglobin level of ≥ 10 g/dL.
    • Adequate hepatic and renal function as defined by serum bilirubin ≤ 25 µmol/L; alkaline phosphatase, alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times the upper limit of normal if no demonstrable liver metastasis or ≤ 5 times the upper limit of normal in the presence of liver metastasis; serum creatinine ≤ 120 µmol/L.
  7. At least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST).
  8. Providing written informed consent and be able to comply with study assessments and follow-up.

EXCLUSION CRITERIA:

  1. Patients who had undergone major surgery, chemotherapy or radiation therapy (except palliative) within the previous 4 weeks.
  2. A known history of hypersensitivity to carboplatin, paclitaxel or any of their excipients.
  3. Previous exposure to DMXAA or other vascular targeting agents.
  4. Small cell lung cancer or mixed histology.
  5. Having received blood transfusions or growth factors to aid haematological recovery within 2 weeks of the scheduled baseline visit.
  6. Active serious infection within 2 weeks of screening.
  7. Clinically significant cardiac arrhythmias and known QTc prolongation.
  8. Evidence of severe or uncontrolled systemic disease that might interfere with study participation.
  9. A history of alcoholism, drug addiction or any psychiatric condition that would impair the patient's ability to comply with study procedures.
  10. Pregnant or lactating women and women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test.
  11. Patients should not have received within the two weeks prior to starting the study or be expected to need during the study period medications known to affect the QT interval or systemic serotonin levels.
  12. Concurrent or previous malignancy of a different tumor type within 5 years of starting the study, except for adequately treated non-melanoma skin cancer or cervical intraepithelial neoplasia.
  13. Clinical or radiological evidence of central nervous system metastases.
  14. Evidence of any other clinically significant disorder or laboratory finding that might compromise patient safety.
  15. Participation in any investigational drug study in which the study drug did not subsequently obtain a product license.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832494

Sponsors and Collaborators
Antisoma Research
Investigators
Principal Investigator: Mark McKeage Auckland Medical School, Auckland, New Zealand
  More Information

No publications provided

Responsible Party: Gary Acton, Chief Medical Officer, Antisoma Research Limited
ClinicalTrials.gov Identifier: NCT00832494     History of Changes
Other Study ID Numbers: AS1404-201
Study First Received: January 29, 2009
Last Updated: January 29, 2009
Health Authority: New Zealand: Medsafe

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vadimezan
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014