CI-1040 in Treating Patients With Advanced Breast, Colon, Pancreatic, or Non-Small Cell Lung Cancer

Breast Cancer Clinical Trial

Official title:

A Multicenter Phase 2 Study of CI-1040 In Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer Or Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033384
• Other study ID #: CDR0000069279
• Secondary ID: UAB-0152PFIZER-1
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2002
• Last updated: April 10, 2013
• Start date: February 2002
• Est. completion date: November 2003

Study information

• Verified date: December 2002
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: CI-1040 may stop the growth of tumors by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of CI-1040 in treating patients who have metastatic or unresectable breast, colon, pancreatic, or non-small cell lung cancer.

Description:

OBJECTIVES:

• Determine the antitumor activity of CI-1040 in patients with non-small cell lung, breast, colon, or pancreatic cancer.

• Determine the safety profile of this drug in these patients.

• Assess quality of life (overall and for each tumor type) of patients treated with this drug.

• Determine the relationship between study drug concentration and antitumor response in these patients and target suppression and safety of this drug.

• Correlate target suppression (pERK) with antitumor effects of this drug in these patients.

• Correlate the mRNA expression profile of the tumors with antitumor effects of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (non-small cell lung vs breast vs colon vs pancreas).

Patients receive oral CI-1040 twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 28 days during the first 6 months of study therapy.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 52-172 patients (13-43 per stratum) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic or inoperable non-small cell lung, breast, or colon cancer or duct cell carcinoma of the exocrine pancreas

• Bidimensionally measurable lesions that are not previously irradiated

• New lesions that have developed in a previously irradiated field may be used as measurable disease

• No brain metastases

• Patients with prior brain metastases are allowed provided they have undergone prior resection of metastases and/or 1 prior course of cranial irradiation, have no new sites of brain metastases since then, have no worsening CNS symptoms, and have discontinued prior corticosteroids for at least 30 days

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Not specified

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)

• AST or ALT no greater than 2 times ULN (5 times ULN if due to liver involvement)

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 30 days after study participation

• Capable of swallowing intact study medication capsules

• Capable of following instructions regarding study medication or has daily caregiver to administer study medication

• No concurrent serious infection

• No life-threatening illness unrelated to tumor

• No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 2 weeks since prior immunotherapy or biologic therapy

Chemotherapy:

• At least 4 weeks since prior cytotoxic chemotherapy

• No more than 1 prior cytotoxic chemotherapy regimen for metastatic non-small cell lung or colon cancer

• No more than 2 prior cytotoxic chemotherapy regimens for breast cancer

• No prior cytotoxic chemotherapy for pancreatic cancer

Endocrine therapy:

• See Disease Characteristics

• At least 2 weeks since other prior hormonal therapy

Radiotherapy:

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• No other concurrent anticancer agents

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Colorectal Cancer
• Lung Cancer
• Lung Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• CI-1040

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,