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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00033384
First received: April 9, 2002
Last updated: April 10, 2013
Last verified: December 2002
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Colorectal Cancer
Lung Cancer
Pancreatic Cancer
Drug: CI-1040
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Study Start Date: February 2002
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033384

Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Study Chair: John J. Rinehart, MD University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00033384     History of Changes
Other Study ID Numbers: CDR0000069279, UAB-0152, PFIZER-1040-002-004, UAB-F011203011, NCI-G02-2052
Study First Received: April 9, 2002
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:
stage III colon cancer
stage IV colon cancer
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
recurrent non-small cell lung cancer
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
recurrent colon cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
duct cell adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Breast Neoplasms
Colonic Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Lung Neoplasms
Pancreatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014