OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer

NCT00081237 | Completed Phase 1

• 2 other identifiers: EORTC-16033OSI-EORTC-16033
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

Brief Summary

RATIONALE: OSI-7904L may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining OSI-7904L with oxaliplatin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of OSI-7904L and oxaliplatin in treating patients with refractory or recurrent advanced colorectal cancer.

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer; stage III colon cancer; stage IV colon cancer; recurrent rectal cancer; stage III rectal cancer; stage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose and recommended dose for future trials as measured by CTC v3.0

Secondary Outcomes (4)

• Safety profile as measured by CTC v3.0

• Response as measured by RECIST every 6 weeks (2 courses)

• Pharmacodynamics as measured by drug concentration in the blood during course 1

• Time to progression as measured by Kaplan Meier and RECIST every 6 weeks during treatment and then every 8 weeks

Interventions

OSI-7904L DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed colorectal cancer * Radiologic evidence of advanced disease * At least 1 measurable lesion at least 20 mm OR at least 10 mm by spiral CT scan * Indicator lesions in a previously irradiated field are allowed provided the irradiated lesion has clearly progressed OR a new lesion has developed in the irradiated field * Failed 1, and only 1, line of prior chemotherapy for advanced/metastatic disease * Disease progression during chemotherapy OR within 6 months after completion of treatment * No symptomatic brain metastases meeting any of the following criteria: * Unstable * Inadequately controlled with fixed-dose oral steroids * Potentially life-threatening * Required radiotherapy with the past 28 days PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * AST and ALT \< 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Bilirubin \< 1.5 times ULN * No hepatitis * No cirrhosis Renal * Creatinine \< 1.5 times ULN Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * HIV negative * No preexisting neuropathy ≥ grade 2 * No active or uncontrolled infection * No other serious illness or medical condition * No chronic alcohol abuse * No known hypersensitivity to systemic liposomal formulations or compounds chemically related to OSI-7904L or oxaliplatin * No prior psychiatric or neurologic condition that would preclude study compliance or giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * At least 21 days since prior immunotherapy * At least 21 days since prior monoclonal antibody therapy Chemotherapy * See Disease Characteristics * At least 21 days since prior chemotherapy and recovered\* * No prior oxaliplatin NOTE: \*Alopecia allowed Endocrine therapy * See Disease Characteristics * At least 21 days since prior hormonal therapy Radiotherapy * See Disease Characteristics * At least 21 days since prior radiotherapy and recovered * No prior radiotherapy to more than 25% of bone marrow reserve Surgery * Recovered from prior surgery Other * At least 21 days since prior tyrosine kinase inhibitor therapy * More than 21 days since prior investigational agents * No other concurrent anticancer therapy * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (2)

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Related Publications (1)

• Clamp AR, Schoffski P, Valle JW, Wilson RH, Marreaud S, Govaerts AS, Debois M, Lacombe D, Twelves C, Chick J, Jayson GC; EORTC New Drug Development Group. A phase I and pharmacokinetic study of OSI-7904L, a liposomal thymidylate synthase inhibitor in combination with oxaliplatin in patients with advanced colorectal cancer. Cancer Chemother Pharmacol. 2008 Apr;61(4):579-85. doi: 10.1007/s00280-007-0509-5. Epub 2007 May 23.

  PMID: 17520255 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

((S)-2-(5-(1,2-dihydro-3-methyl-1-oxobenzo(f)-quinazoline-9-yl)methyl)amino-1-oxo-2-isoindolynyl)-glutaric acid; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Patrick Schoffski, MD, MPH

  Hannover Medical School

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Study Start: February 1, 2004
• Primary Completion: August 1, 2005
• Last Updated: June 12, 2013

Record last verified: 2013-06

Locations

DE (1); GB (1)