Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Breast Cancer, Colorectal Cancer, Lung Cancer, Pancreatic Cancer

Thank you

Trial Information

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


- 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

- 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

- 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

Inclusion Criteria


- 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



- 18 and over


- Not specified

Menopausal status:

- Not specified

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


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

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


- 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)


- Creatinine no greater than 1.5 times ULN


- Not pregnant or nursing

- Negative pregnancy test

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

- 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


Biologic therapy:

- At least 2 weeks since prior immunotherapy or biologic therapy


- 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


- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy


- See Disease Characteristics


- No other concurrent anticancer agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

John J. Rinehart, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham


United States: Food and Drug Administration

Study ID:




Start Date:

February 2002

Completion Date:

November 2003

Related Keywords:

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



University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300