Clinical trial NCT00087191: EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer
Official title: Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Advanced Adult Primary Liver Cancer
Carcinoma of the Appendix
Fallopian Tube Cancer
Gastrointestinal Stromal Tumor
Localized Extrahepatic Bile Duct Cancer
Localized Gallbladder Cancer
Localized Gastrointestinal Carcinoid Tumor
Localized Resectable Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Metastatic Gastrointestinal Carcinoid Tumor
Ovarian Sarcoma
Ovarian Stromal Cancer
Primary Peritoneal Cavity Cancer
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
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
Unresectable Extrahepatic Bile Duct Cancer
Unresectable Gallbladder Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Motexafin lutetium uptake in tumors and normal tissues
timeFrame: At the time of surgery
measure: Tumor to normal tissue ration (TNTR) of motexafin lutetium for any tumor and normal tissue
timeFrame: At the time of surgery
measure: Pattern and presence of EF5 binding
timeFrame: At the time of surgery
measure: Toxicity as assessed by NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
timeFrame: Up to 60 days following EF5 infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of The University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Stephen Michael Hahn
role: PRINCIPAL_INVESTIGATOR
References: