MDACC Study Summary 2004-0091

Study Summary
No. 2004-0091:.......Lung; Cancer Control......Frank V. Fossella......Thoracic and Head and Neck Medical Oncology

Study Summary Title



Study Summary Number:	2004-0091

Study Title:	A Phase II Timing Study of Technetium 99m Tc-Hynic-rh-Annexin V for Imaging of Apoptosis in Patients with Lung Cancer

Physician

New Patient Referral



Name:	Frank V. Fossella	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Thoracic and Head and Neck Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6363 Contact us about clinical trials

General Information



Disease Group:	Lung Cancer Control	Supported By:	Theseus Imaging Corporation

Phase of Study:	Phase II	Return Visit:	Extra visits occur 1 to 7 days before chemotherapy and 1, 3, and 7 days after chemotherapy. These extra visits occur during chemotherapy cycles 1, 2, 4, and 6.

Treatment Agents:	Imaging	Home Care:	N/A

Treatment Loc:	outpatient

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

Unavailable

Study Status Information



Study Activation / Registration Date:	04/26/2004

IRB Review and Approval Date:	03/03/2004

Study Type:	Diagnostic

Recruitment Status:	Closed

Projected Accrual:	10

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

Pt. must have microscopically confirmed stage IIIB or stage IV chemo-naive NSCLS meeting one of the following classifications: Large cell carcinoma, Squamous cell carcinoma, Adenocarcinoma that is not bronchoalveolarcarcinoma, mucoepidermoid tumor, adenoid cystic carcinoma, or carcinoid- Undifferentiated non-small cell carcinoma (NSCLS unable to be classified further).

Patient must have one or more thoracic lesions measurable in at least one dimension on chest CT, with at least one lesion ("index lesion") measuring a minimum of 2.0 cm in the longest diameter (LD).

Patient must be at least 18 years of age.

Patient must have a Baseline Eastern Collaborative Oncology Group (ECOG) Performance Status (EPS) score of 0 or 1 (see Appendix 1) or its equivalent.

Patient must have an estimated life expectancy (with treatment) of 16-24 weeks.

Female patients must have a history of or documentation of an inability to bear children, i.e., hysterectomy or at least one year post surgical sterilization or menopause.

Patient must be scheduled for up to 6 cycles of chemo with carboplatin (AUC 6.0 given IV on day 1 of a 21-28 day treatment cycle) and paclitaxel 135 to 225 mg/m(2) given on day 1 of a 21-28 day treatment cycle unless in the judgment of the treating oncologist the pt. condition requires that the paclitaxel be admin. in an equivalent dose divided weekly).

Adequate hepatic function determined within 2 weeks prior to the initial dose of NAS 2020 and defined as total bilirubin no greater than 1.5 times the upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no greater than 2.5 ULN (5x ULN for pts. with documented liver mets).

Adequate renal function determined within 2 weeks prior to the initial dose of NAS 2020 and defined as blood urea nitrogen (BUN) no greater than 1.5 times ULN and serum creatinine no greater than 1.5 times ULN.

Adequate blood coagulation factors determined within 7 days prior to the initial dose of NAS 2020 and defined as prothrombin time (PT) no greater than 1.5 times control and activated partial thromboplastin time (aPTT) no greater than 1.5 times control.

Adequate hematologic parameters determined within 2 weeks prior to the initial dose of NAS 2020 and defined as hemoglobin equal to or greater than 10.0 gm%, ANC equal to or greater than 1500 ul, and platelet count equal to or greater than 100,000/ul.

Patient must give written informed consent prior to enrollment in the study.

Exclusion Criteria:

Patient has received prior radiotherapy to the primary or other target lesion(s) or is to receive radiotherapy to the primary or other target lesion(s) prior to the follow-up chest CT. (Planned radiotherapy to a metastatic brain or bone lesion is allowed).

Patient is to have surgical resection of the primary or index lesion prior to the follow-up chest CT.

Patient is clinically unstable and unlikely to be available for follow-up.

Female patient is pregnant or lactating.

Female patient is of future childbearing potential. Female patients must be post-hysterectomy or at least one year post-menopause or surgical sterilization.

Patient receiving heparin, coumadin, or other anticoagulant medication other than aspirin (except low dose anticoagulant medication for maintenance of indwelling infusion catheter, so long as coagulation factors satisfy Inclusion Criteria requirement in Section 9.1.10).

Patient is scheduled to undergo major surgery within two weeks before the study, or after commencement of the study and before the final 99m TC Hynic-rh-Annexin V imaging study.

Patients who have been imaged with Technetiuim 99m Tc in the previous 48 hours or with Gallium 67 Ga, Indium 111IN, or Thallium 201 T1 in the last seven days.

Known allergy to Kanamycin.

Links

Registration Number: