Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00274872
Other study ID # CDR0000453890
Secondary ID GERCOR-OPTIMOX2G
Status Active, not recruiting
Phase Phase 2/Phase 3
First received January 10, 2006
Last updated January 29, 2010
Start date January 2004

Study information

Verified date May 2007
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.

PURPOSE: This randomized phase II/III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer that cannot be removed by surgery.


Description:

OBJECTIVES:

Primary

- Compare progression-free survival of patients with inoperable metastatic colorectal cancer treated with oxaliplatin, leucovorin calcium, and fluorouracil with vs without maintenance leucovorin calcium and fluorouracil.

- Demonstrate that time of disease control (TDC) can be increased by 15% at 9 months and that maintenance therapy can be avoided.

Secondary

- Compare the overall survival and response rate in patients treated with these regimens.

- Compare the salvage surgery rate in patients treated with these regimens.

- Compare the tolerability of these regimens in these patients.

- Compare the quality of life in patients treated with these regimens.

- Compare the duration of chemotherapy-free intervals in patients treated with these regimens.

- Compare the pharmacoeconomy and pharmacogenetics of these regimens in these patients.

OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to participating center, performance status (0-1 vs 2), number of metastatic sites (1 vs > 1), age (18-50 years vs 51-75 years vs 76-80 years), adjuvant chemotherapy, and baseline alkaline phosphatase (≤ 3 times upper limit of normal [ULN] vs > 3 times ULN). Patients are randomized to 1 of 2 treatment arms.

Arm I

- FOLFOX chemotherapy: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance chemotherapy.

- Maintenance chemotherapy: Patients receive leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Patients with disease progression on maintenance chemotherapy receive 6 additional courses of FOLFOX as above. Patients with continued disease progression while receiving the additional courses of FOLFOX proceed to irinotecan-based chemotherapy off study.

Arm II

- FOLFOX chemotherapy: Patients receive 6 courses of FOLFOX as in arm I. Patients with disease progression on FOLFOX receive 6 additional courses of FOLFOX. Patients with continued disease progression while receiving the additional courses of FOLFOX proceed to irinotecan-based chemotherapy off study.

In both arms, patients with stable or responding disease may undergo surgical resection after completion of the initial 6 courses of FOLFOX.

Quality of life is assessed at baseline, after courses 4 and 6, and then every 2-3 months thereafter.

After completion of study treatment, patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 600
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility DISEASE CHARACTERISTICS:

- Histologically proven adenocarcinoma of the colon or rectum

- Metastatic disease

- No metastases involving only the bone

- Inoperable disease (i.e., not suitable for complete surgical resection)

- Measurable or evaluable disease

- Measurable disease defined as = 1 unidimensionally measurable lesion = 20 mm by conventional CT scan OR = 10 mm by spiral CT scan

- No symptomatic ascites or pleural effusion that has not been evacuated

- No CNS metastasis

PATIENT CHARACTERISTICS:

- WHO OR ECOG performance status 0-2

- Absolute neutrophil count = 1,500/mm^3

- Platelets = 100,000/mm^3

- Creatinine < 3 times upper limit of normal (ULN)

- Alkaline phosphatase < 5 times ULN

- No peripheral neuropathy = grade 1

- No total or partial bowel obstruction

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No uncontrolled hypercalcemia

- No other concurrent or prior malignancy, except adequately treated carcinoma in situ of the uterine cervix or basal or squamous cell carcinoma of the skin or cancer in complete remission for = 5 years

- No uncontrolled congestive heart failure

- No angina pectoris

- No hypertension

- No arrhythmias

- No history of significant neurologic or psychiatric disorders

- No active infection

- No other serious nonmalignant disease

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy and/or immunotherapy for metastatic disease

- Prior adjuvant chemotherapy allowed provided progression-free interval after completion of adjuvant chemotherapy is > 6 months

- No other concurrent anticancer treatment

- No participation in another clinical trial with any investigational drug within 30 days prior to randomization

- No other concurrent investigational treatment

- No concurrent radiotherapy

- No concurrent cold cap for prevention of alopecia or iced mouth rinses for prevention of stomatitis

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
fluorouracil

leucovorin calcium

oxaliplatin


Locations

Country Name City State
France Hopital Duffaut Avignon
France Institut Sainte Catherine Avignon
France Infirmerie Protestante Caluire
France Hopital Drevon Dijon
France Centre Hospitalier de Dreux Dreux
France Hopital Louis Pasteur - Le Coudray Le Coudray
France Clinique Victor Hugo Le Mans
France Hopital Robert Boulin Libourne
France Clinique Saint Jean Lyon
France Intercommunal Hospital Montfermeil
France Hopital Europeen Georges Pompidou Paris
France Hopital Saint Antoine Paris
France Hopital Tenon Paris
France Polyclinique De Courlancy Reims
France C.H. Senlis Senlis
France Clinique des Jockeys Senlis
France Centre Medico-Chirurgical Foch Suresnes

Sponsors (1)

Lead Sponsor Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

References & Publications (1)

Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, André T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic col — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival No
Primary Time to disease control No
Primary Response as measured by RECIST criteria No
Primary Toxicity Yes
Primary Quality of life as assessed by EUROQOL- 5 Dimensional Instrument or Functional Assessment of Cancer Therapy-Neurotoxicity module version 4.0 at baseline and periodically during study treatment Yes
Primary Pharmaco-economic evaluation No
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT00098787 - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05425940 - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer Phase 3
Suspended NCT04595604 - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery. N/A
Completed NCT03414125 - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening N/A
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT03874026 - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03167125 - Participatory Research to Advance Colon Cancer Prevention N/A
Completed NCT03181334 - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation N/A
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Recruiting NCT05568420 - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting NCT02972541 - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer N/A
Completed NCT02876224 - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors Phase 1
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A