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

National Cancer Institute (NCI)

Status

Terminated

Conditions

Regional Gastrointestinal Carcinoid Tumor

Stage IV Gastric Cancer

Stage IV Non-small Cell Lung Cancer

Stage IV Adult Soft Tissue Sarcoma

Recurrent Ovarian Germ Cell Tumor

Stage II Rectal Cancer

Fallopian Tube Cancer

Carcinoma of the Appendix

Stage I Colon Cancer

Stage I Rectal Cancer

Stage II Adult Soft Tissue Sarcoma

Stage I Pancreatic Cancer

Advanced Adult Primary Liver Cancer

Small Intestine Lymphoma

Primary Peritoneal Cavity Cancer

Stage III Uterine Sarcoma

Recurrent Uterine Sarcoma

Small Intestine Adenocarcinoma

Small Intestine Leiomyosarcoma

Recurrent Pancreatic Cancer

Stage I Ovarian Germ Cell Tumor

Stage III Pancreatic Cancer

Metastatic Gastrointestinal Carcinoid Tumor

Recurrent Small Intestine Cancer

Recurrent Ovarian Epithelial Cancer

Unresectable Gallbladder Cancer

Stage IIIA Non-small Cell Lung Cancer

Recurrent Non-small Cell Lung Cancer

Recurrent Adult Soft Tissue Sarcoma

Stage IV Rectal Cancer

Stage IV Colon Cancer

Ovarian Sarcoma

Localized Extrahepatic Bile Duct Cancer

Stage II Pancreatic Cancer

Recurrent Gastrointestinal Carcinoid Tumor

Recurrent Rectal Cancer

Stage III Gastric Cancer

Stage III Rectal Cancer

Stage I Uterine Sarcoma

Recurrent Gallbladder Cancer

Stage II Colon Cancer

Localized Gallbladder Cancer

Gastrointestinal Stromal Tumor

Stage IV Ovarian Epithelial Cancer

Stage III Ovarian Germ Cell Tumor

Unresectable Extrahepatic Bile Duct Cancer

Recurrent Extrahepatic Bile Duct Cancer

Stage III Ovarian Epithelial Cancer

Stage II Non-small Cell Lung Cancer

Recurrent Gastric Cancer

Stage I Non-small Cell Lung Cancer

Stage II Gastric Cancer

Stage III Colon Cancer

Stage I Gastric Cancer

Stage II Ovarian Germ Cell Tumor

Stage 0 Non-small Cell Lung Cancer

Stage III Adult Soft Tissue Sarcoma

Recurrent Adult Primary Liver Cancer

Stage II Uterine Sarcoma

Recurrent Colon Cancer

Stage I Adult Soft Tissue Sarcoma

Stage IV Uterine Sarcoma

Stage IV Pancreatic Cancer

Localized Unresectable Adult Primary Liver Cancer

Stage I Ovarian Epithelial Cancer

Stage IV Ovarian Germ Cell Tumor

Localized Resectable Adult Primary Liver Cancer

Stage IIIB Non-small Cell Lung Cancer

Stage II Ovarian Epithelial Cancer

Ovarian Stromal Cancer

Localized Gastrointestinal Carcinoid Tumor

Treatments

Drug: motexafin lutetium

Drug: EF5

Other: pharmacological study

Study type

Interventional

Funder types

NIH

Identifiers

NCT00087191

NCI-2012-02607

UPCC# 04204

P01CA087971 (U.S. NIH Grant/Contract)

CDR0000373812 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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