A Combination Study to Determine the Safety and Efficacy of Panzem NCD With Avastin in Metastatic Carcinoid Tumors
This study has been completed.
Sponsor:
EntreMed
Information provided by:
EntreMed
ClinicalTrials.gov Identifier:
NCT00328497
First received: May 18, 2006
Last updated: March 9, 2010
Last verified: March 2010
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Purpose
This single center, open-label study will evaluate the safety and efficacy of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Dispersion (NCD) administered orally with recombinant human monoclonal antibody against vascular endothelial growth factor (bevacizumab) administered intravenously, in patients with locally advanced or metastatic carcinoid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoid Tumor |
Drug: Panzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1-2 Safety and Efficacy Study of Panzem Nanocrystal Colloidal Dispersion Administered Orally in Combination With rhuMAb VEGF (Bevacizumab) in Patients With Locally Advanced or Metastatic Carcinoid Tumors |
Resource links provided by NLM:
Further study details as provided by EntreMed:
Primary Outcome Measures:
- To assess the safety of Panzem NCD administered orally in combination with intravenous infusion of bevacizumab by evaluation of the frequency and severity of treatment emergent adverse events [ Time Frame: Approximately monthly ] [ Designated as safety issue: Yes ]
- To evaluate the objective tumor response rate by radiographic means using Response Evaluation Criteria in Solid Tumors [ Time Frame: Approximately every 8 weeks ] [ Designated as safety issue: No ]
- To determine the overall survival of patients with locally advanced or metastatic carcinoid tumors administered oral Panzem NCD in combination with intravenous infusion of bevacizumab [ Time Frame: Approximately every 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine the progression-free survival of patients with locally advanced or metastatic carcinoid tumors administered oral Panzem NCD in combination with intravenous infusion of bevacizumab [ Time Frame: Approximately every 3 months ] [ Designated as safety issue: No ]
- To monitor the steady-state trough plasma levels of 2ME2 following 28-day dosing cycles of Panzem NCD when administered orally in combination with intravenous infusion of bevacizumab [ Time Frame: Approximately monthly ] [ Designated as safety issue: Yes ]
| Enrollment: | 31 |
| Study Start Date: | May 2006 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Panzem NCD will be dosed orally at a level of 1,000 mg, four times daily for 28 consecutive days and bevacizumab will be administered at a dose of 5 mg/kg as an intravenous bolus on Day 1 and Day 15 of the Treatment Period
|
Drug: Panzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab)
Panzem NCD 1,000 mg, four times daily for 28 consecutive days bevacizumab 5 mg/kg intravenous bolus on Day 1 and Day 15
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically documented locally unresectable or metastatic carcinoid neuroendocrine tumor
- Measurable disease, according to RECIST, with at least one lesion that is unidimensionally measurable by conventional techniques to be greater than or equal to 2 cm in diameter, or by spiral CT to be greater than or equal to 1 cm in diameter
- 18 years or older
Laboratory data to include (next 7 bullet points):
- Aspartate aminotransferase(AST)and alanine aminotransferase (ALT)less than 2.5 times the upper limit of normal (less than 5 times upper limit of normal if liver metastasis present)
- Total bilirubin less than or equal to 2 mg/dL
- Serum creatinine less than or equal to 1.5 mg/dL
- Total white blood cell count greater than 3,500/mm3
- Absolute neutrophil count greater than or equal to 1,500/mm3
- International normalized ratio less then or equal to 1.5
- Platelets greater than or equal to 100,000/mm3
- Agree to use effective contraceptive methods
- Have an ECOG performance status of less than 2
- Life expectancy of greater than 12 weeks
- Ability to understand the requirements of the study, have provided written consent, and agree to abibe by the study restrictions
Exclusion Criteria:
- Pregnant or nursing, or refusal to use appropriate birth control
- An active infection
- Have a history of myocardial infarction or angina pectoris/angina equivalent in the last 12 months (the patient may be on antianginal medications if the symptoms can be fully controlled), or have uncontrolled congestive heart failure
- Have apparent central nervous system metastasis or carcinomatous meningitis
- Have had any active cancer in addition to the carcinoid tumor within the last 5 years, with the exception of superficial skin cancer
- Be receiving concurrent treatment with therapeutic doses of any anticoagulant including all forms of heparin and Coumadin
- Have current or a history of severe bleeding
- Uncontrolled / severe hypertension
- Previous history of nephrotic syndrome
- Urine protein: creatinine ratio greater than or equal to 1.0 at screening
- Have received radiotherapy or chemotherapy within the previous 4 weeks
- Participated in any clinical trial involving conventional or investigational drugs or devices within the previous 4 weeks
- Have had major surgery within 4 weeks or plan to undergo elective surgery during treatment
- Additional uncontrolled serious medical condition or psychiatric illness
- Have any condition that is likely to interfere with regular follow-up
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328497
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
EntreMed
Investigators
| Principal Investigator: | Matthew H. Kulke, M.D. | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Carolyn F. Sidor, MD, MBA; Chief Medical Officer, EntreMed, Inc. |
| ClinicalTrials.gov Identifier: | NCT00328497 History of Changes |
| Other Study ID Numbers: | ME-CLN-002 |
| Study First Received: | May 18, 2006 |
| Last Updated: | March 9, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoid Tumor Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue 2-methoxyestradiol Bevacizumab |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013