NCT00165867

Brief Summary

The overall purpose of this study is to determine the efficacy, safety and tolerability of indisulam in combination with irinotecan as a treatment for patients with metastatic colorectalcancer previously treated with 5-fluorouracil/leucovorin and oxaliplatin (FOLFOX).

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

October 9, 2006

Status Verified

October 1, 2006

First QC Date

September 13, 2005

Last Update Submit

October 6, 2006

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • The objective response rate as defined by RECIST criteria.

Secondary Outcomes (4)

  • Duration of response

  • time to progression

  • overall survival

  • safety and tolerability of the combination

Interventions

E7070DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ambulant male or female patients with metastatic colorectal cancer who have been previously treated with 5-fluorouracil/leucovorin and oxaliplatin. Patients must fulfill the following criteria to be included in the study:
  • At least 4 doses of previous treatment with oxaliplatin
  • All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have resolved
  • At least one uni-dimensionally measurable lesion according to RECIST criteria (the following do not qualify as measurable lesions: bone, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions)
  • Aged greater than or equal to 18 years
  • Histologically or cytologically confirmed colorectal cancer
  • Karnofsky performance status greater than or equal to 70%
  • Written informed consent to participate in the study

You may not qualify if:

  • Patients with the following characteristics will not be included in the study:
  • More than three previous lines of chemotherapy (including neo-adjuvant and adjuvant)
  • Prior treatment with cytotoxics other than 5- fluorouracil/leucovorin (capecitabine and UFT are permitted) and oxaliplatin. Prior epidermal growth factor receptor targeted and anti-angiogenic therapy is permitted.
  • Untreated brain metastases (patients who have been treated for CNS metastases must be asymptomatic and radiologically stable for 4 weeks prior to entry). Patients must not have clinical symptoms from brain metastases and must not be taking corticosteroids for the treatment of brain metastases. Patients must not have leptomeningeal metastases
  • Any of the following laboratory parameters:
  • hemoglobin \<10 g/dl;
  • neutrophils \<1.5 x 109/L;
  • platelets \<100 x 109/L;
  • serum bilirubin \>25 mmol/l (1.5 mg/dl);
  • other liver parameters \>2.5 x upper normal limit (ULN) (\> 5 x upper normal limit in the presence of hepatic metastases);
  • serum creatinine \>1.5 x ULN;
  • serum calcium (corrected for albumin) \>=11.5 mg/dl. 5. History of Gilbert's Disease or conjugated hyperbilirubinemia 6. Concurrent or previous malignancy of a different tumor type within five years of starting the study except for adequately treated non- melanoma skin cancer or cervical intraepithelial neoplasia
  • Uncontrolled infections
  • Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start
  • Chronic inflammatory bowel disease and/or bowel obstruction
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hôpitaux Civils de Colmar

Colmar, F- 68024, France

Location

CRLC Val d'Aurelle

Montpellier, F-34298, France

Location

Centre Antoine Lacassagne

Nice, F-06189, France

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Beatson Oncology Centre

Glasgow, G11 6NT, United Kingdom

Location

Cookridge Hospital

Leeds, LS16 6QB, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jantien Wanders

    Eisai Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 14, 2005

Study Start

April 1, 2005

Last Updated

October 9, 2006

Record last verified: 2006-10

Locations

GB(4)FR(3)