EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer

Fallopian Tube Cancer Clinical Trial

Official title:

Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00087191
• Other study ID #: NCI-2012-02607
• Secondary ID: UPCC# 04204P01CA
• Status: Terminated
• Phase: N/A
• First received: July 8, 2004
• Last updated: January 15, 2013
• Start date: May 2004

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This clinical trial is studying the amount of EF5 and motexafin lutetium present in tumor cells and/or normal tissues of patients with abdominal (such as ovarian, colon, or stomach cancer) or non-small cell lung cancer. EF5 may be effective in measuring oxygen in tumor tissue. Photosensitizing drugs such as motexafin lutetium are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. Knowing the level of oxygen in tumor tissue and the level of motexafin lutetium absorbed by tumors and normal tissue may help predict the effectiveness of anticancer therapy

Description:

OBJECTIVES:

I. Determine the uptake of motexafin lutetium in tumors and normal tissue of patients with intra-abdominal malignancies or non-small cell lung cancer.

II. Determine the ratio of tumor to normal tissue by measuring the level of motexafin lutetium uptake in tumor and normal tissue removed from these patients.

III. Determine the pattern, presence, and level of EF5 binding (as a surrogate marker for hypoxia) in tumors of these patients.

IV. Determine the feasibility of measuring optical properties, tissue oxygenation, motexafin lutetium concentration, fluorescence, and blood flow by non-invasive means in these patients.

OUTLINE: This is a multicenter, diagnostic study. Patients are stratified according to diagnosis (intra-abdominal malignancy vs non-small cell lung cancer).

Patients receive EF5 IV over 1-2.5 hours on day 1 and motexafin lutetium IV over 10-15 minutes on day 2. Patients undergo definitive surgical resection approximately 3 hours after motexafin lutetium administration. Hypoxia and motexafin lutetium levels in the resected tumors are evaluated. Tumor to normal tissue ratios are also determined.

After completion of study treatment, patients are followed at approximately 1-8 weeks.

PROJECTED ACCRUAL: A total of 30 patients (20 with intra-abdominal malignancies and 10 with non-small cell lung cancer) will be accrued for this study within 10-15 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed or suspected diagnosis of 1 of the following:

• Intra-abdominal malignancy of 1 of the following types:

• Sarcoma

• Ovarian cancer

• Gastrointestinal malignancies, including, but not limited to, appendiceal cancer, colon cancer, or gastric cancer

• Non-small cell lung cancer

• Planning to undergo surgical resection of disease

• Disease has the propensity to spread to the peritoneal cavity (intra-abdominal malignancy patients)

• Performance status - ECOG 0-2

• WBC = 2,000/mm^3

• Platelet count = 100,000/mm^3

• Bilirubin < 1.5 mg/dL

• Creatinine normal

• Creatinine clearance = 60 mL/min

• Body weight = 130 kg

• No G6PD deficiency

• No porphyria

• No history of peripheral neuropathy = grade 3

• Able to tolerate anesthesia and major surgery

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 1 month after study participation

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Adult Primary Liver Cancer
• Appendiceal Neoplasms
• Bile Duct Neoplasms
• Carcinoid Tumor
• Carcinoma of the Appendix
• Carcinoma, Non-Small-Cell Lung
• Cholangiocarcinoma
• Fallopian Tube Cancer
• Gallbladder Neoplasms
• Gastrointestinal Neoplasms
• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Germinoma
• Leiomyosarcoma
• Liver Neoplasms
• Localized Extrahepatic Bile Duct Cancer
• Localized Gallbladder Cancer
• Localized Gastrointestinal Carcinoid Tumor
• Localized Resectable Adult Primary Liver Cancer
• Localized Unresectable Adult Primary Liver Cancer
• Lung Neoplasms
• Malignant Carcinoid Syndrome
• Metastatic Gastrointestinal Carcinoid Tumor
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Glandular and Epithelial
• Neuroendocrine Tumors
• Ovarian Neoplasms
• Ovarian Sarcoma
• Ovarian Stromal Cancer
• Pancreatic Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer
• Rectal Neoplasms
• Recurrent Adult Primary Liver Cancer
• Recurrent Adult Soft Tissue Sarcoma
• Recurrent Colon Cancer
• Recurrent Extrahepatic Bile Duct Cancer
• Recurrent Gallbladder Cancer
• Recurrent Gastric Cancer
• Recurrent Gastrointestinal Carcinoid Tumor
• Recurrent Non-small Cell Lung Cancer
• Recurrent Ovarian Epithelial Cancer
• Recurrent Ovarian Germ Cell Tumor
• Recurrent Pancreatic Cancer
• Recurrent Rectal Cancer
• Recurrent Small Intestine Cancer
• Recurrent Uterine Sarcoma
• Regional Gastrointestinal Carcinoid Tumor
• Sarcoma
• Small Intestine Adenocarcinoma
• Small Intestine Leiomyosarcoma
• Small Intestine Lymphoma
• Stage 0 Non-small Cell Lung Cancer
• Stage I Adult Soft Tissue Sarcoma
• Stage I Colon Cancer
• Stage I Gastric Cancer
• Stage I Non-small Cell Lung Cancer
• Stage I Ovarian Epithelial Cancer
• Stage I Ovarian Germ Cell Tumor
• Stage I Pancreatic Cancer
• Stage I Rectal Cancer
• Stage I Uterine Sarcoma
• Stage II Adult Soft Tissue Sarcoma
• Stage II Colon Cancer
• Stage II Gastric Cancer
• Stage II Non-small Cell Lung Cancer
• Stage II Ovarian Epithelial Cancer
• Stage II Ovarian Germ Cell Tumor
• Stage II Pancreatic Cancer
• Stage II Rectal Cancer
• Stage II Uterine Sarcoma
• Stage III Adult Soft Tissue Sarcoma
• Stage III Colon Cancer
• Stage III Gastric Cancer
• Stage III Ovarian Epithelial Cancer
• Stage III Ovarian Germ Cell Tumor
• Stage III Pancreatic Cancer
• Stage III Rectal Cancer
• Stage III Uterine Sarcoma
• Stage IIIA Non-small Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Stage IV Adult Soft Tissue Sarcoma
• Stage IV Colon Cancer
• Stage IV Gastric Cancer
• Stage IV Non-small Cell Lung Cancer
• Stage IV Ovarian Epithelial Cancer
• Stage IV Ovarian Germ Cell Tumor
• Stage IV Pancreatic Cancer
• Stage IV Rectal Cancer
• Stage IV Uterine Sarcoma
• Stomach Neoplasms
• Unresectable Extrahepatic Bile Duct Cancer
• Unresectable Gallbladder Cancer

Intervention

Drug:
• EF5
Given IV
• motexafin lutetium
Given IV

Other:
• pharmacological study
Correlative studies

Locations

Country	Name	City	State
United States	Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motexafin lutetium uptake in tumors and normal tissues	Data will be described using graphical techniques (e.g., box plots) and summary statistics (e.g., means, medians, standard deviations, and interquartile ranges). For each patient, the mean concentration of motexafin lutetium across tumor and normal samples will be summarized.	At the time of surgery	No
Primary	Tumor to normal tissue ration (TNTR) of motexafin lutetium for any tumor and normal tissue	Summary data for each patient will be used to construct a TNTR. Wilcoxon signed rank test of whether the median ration exceeds will be carried out.	At the time of surgery	No
Primary	Pattern and presence of EF5 binding	EF5 biding will be quantified.	At the time of surgery	No
Primary	Toxicity as assessed by NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0	Will be graded, tabled for each stratum and for the entire study and summarized by frequencies and percentages.	Up to 60 days following EF5 infusion	Yes