Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone

• Sponsor: Medivation, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00890305
• Collaborator: (none)
• Enrollment: 171
• Locations: 31
• Arms: 2
• Duration (Months): 46
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This clinical trial will be performed in previously untreated patients with metastatic colorectal cancer. The study will evaluate the safety, tolerability and efficacy of the study drug, CT-011, in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer	Drug: CT-011; Drug: FOLFOX	Phase 2

Detailed Description

The proposed clinical trial will be a multi-center, randomized, open label, active control study in previously untreated patients with metastatic colorectal cancer aimed to evaluate the safety, tolerability and efficacy of the monoclonal antibody, CT-011, administered at 3mg/kg in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone. Approximately 168 patients are planned to be enrolled to this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 171 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone Administered Intravenously to Patients With Colorectal Adenocarcinoma Previously Untreated for Metastatic Disease
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CT-011 in combination with FOLFOX CT-011 (3 mg/kg) administered intravenously every 4 weeks for 4 weeks and every 12 weeks thereafter until disease progression or maximum tolerance. FOLFOX (FOLFOX4 or mFOLFOX6) administered 7 days after the first administration of CT-011 and repeated every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation.	Drug: CT-011; Drug: FOLFOX; FOLFOX-4: each cycle consists of the following: oxaliplatin 85 mg/m2 on Day 1, leucovorin 200 mg/m2/day on Day 1 and Day 2 followed by 5-FU 400 mg/m2 bolus and a 22 hour infusion of 5-FU 600 mg/m2 for two consecutive days. mFOLFOX-6: each cycle consists of the following: oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 on Day 1, followed by 5-FU 400 mg/m2 bolus, followed by 5-FU 1200 mg/m2/day for two consecutive days (total 2,400 mg/m2 over 46-48 hours).
Active Comparator: FOLFOX FOLFOX (FOLFOX-4 or mFOLFOX6) administered every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation.	Drug: FOLFOX; FOLFOX-4: each cycle consists of the following: oxaliplatin 85 mg/m2 on Day 1, leucovorin 200 mg/m2/day on Day 1 and Day 2 followed by 5-FU 400 mg/m2 bolus and a 22 hour infusion of 5-FU 600 mg/m2 for two consecutive days. mFOLFOX-6: each cycle consists of the following: oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 on Day 1, followed by 5-FU 400 mg/m2 bolus, followed by 5-FU 1200 mg/m2/day for two consecutive days (total 2,400 mg/m2 over 46-48 hours).

Outcome Measures

Primary Outcome Measures

1. The primary endpoint will be the median progression free survival in patients treated with CT-011 plus FOLFOX compared to that of patients treated with FOLFOX alone. [32 months]

Secondary Outcome Measures

1. Composite of safety, tolerability, pharmacokinetics and immunogenicity of CT-011. [32 months]

2. Anti tumor activity of the antibody. [32 months]

3. Objective response rate by RECIST. [32 months]

4. Progression-free survival rates. [32 months]

5. Response duration. [32 months]

6. Overall survival. [32 months]

7. Tumor and immunological markers. [32 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient's age is 18 years or older, both genders.

2. Patients with metastatic disease who are eligible for first line FOLFOX chemotherapy. Adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.

3. ECOG performance status ≤ 1

4. At least 4 weeks from prior major surgery or radiotherapy.

5. Life expectancy >3 months

6. Hematology: ANC ≥ 1.5X109/L; Platelets >100x109/L.

7. Adequate Renal function

8. Adequate Hepatic functions

9. Normal Cardiac function

Exclusion Criteria:

1. Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.

2. Patients who had received Oxaliplatin within 12 months prior to diagnosis of metastatic disease.

3. Patients on concurrent anti cancer therapy other than that allowed in the study.

4. Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids

5. Presence of clinically apparent or suspected brain metastasis.

6. Patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months.

7. Serious active infection at the time of pre-study screening.

8. Active or history of autoimmune disorders/conditions.

9. Women who are pregnant or lactating

10. Concurrent active malignancy.

11. Ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.

12. Other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.

13. Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.

14. Patients with history of life threatening allergic reactions to food or drugs

15. Patients with symptomatic peripheral neuropathy> Grade 1.

16. Known positive HIV, Hepatitis B surface antigen or Hepatitis C antibody.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Cancer Center of Huntsville, PC	Huntsville	Alabama	United States	35801
2	University of South Florida	Tampa	Florida	United States	33606
3	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10017
4	Signal Point Clinical Research Center	Middletown	Ohio	United States	45042
5	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas	United States	79410
6	MHAT "Dr. Tota Venkova"	Gabrovo		Bulgaria
7	InterDistrict Dispensary in Oncology Diseases with Stationary-Ruse, EOOD	Ruse		Bulgaria
8	InterDistrict Dispensary in Oncology Diseases with Stationary	Shumen		Bulgaria
9	Multiprofile Hospital for Active Treatment "Tsaritza Joanna"	Sofia		Bulgaria
10	Specialized Hospital for Active Treatment for Oncology	Sofia		Bulgaria
11	InterDistrict Dispensary of Oncology Diseases with Stationary	Varna		Bulgaria
12	Multiprofile Hospital for Active Treatment "Sv. Marina", EAD,	Varna		Bulgaria
13	Regional Cancer Centre, Indira Gandhi Institute of Medical Sciences	Sheikhpura, Patna	Bihar	India	800 014
14	Cancer Clinic	Nagpur	Maharashtra	India	440012
15	Curie Manavata Cancer Centre, Opp.	Nashik	Maharashtra	India	422004
16	Ruby Hall Clinic	Pune	Maharashtra	India	411001
17	Deenanath Mangeshkar Hospital and Research Centre	Pune	Maharashtra	India	411004
18	G. Kuppuswamy Naidu Memorial Hospital	Pappanaickenpalayam, Coimbatore	Tamilnadu	India	641037
19	Hospital Almanzor Aguinaga Asenjo - Chiclayo	Chiclayo		Peru
20	Clinica Ricardo Palma	Lima		Peru
21	Hospital Regional nivel III Cayetano Heredia Essalud Piura	Piura		Peru
22	Ponce School of Medicine/CAIMED Center	Ponce		Puerto Rico	00716
23	Fundacion de Investigacion de Diego	Santurce		Puerto Rico	00909
24	"Prof. Dr. Ion Chiricuţă" Institute of Oncology	Cluj-Napoca		Romania	400015
25	Clinical Emergency Hospital - Oncology Department	Constanta		Romania	900591
26	Oncolab SRL, No. 1	Craiova		Romania	200535
27	Center of Medical Oncology	Iasi		Romania
28	Clinical Hospital Pelican Oradea	Oradea		Romania	410469
29	No. 1 City Hospital	Ploiesti		Romania
30	"Sf. Ioan cel Nou" Clinical Emergency County Hospital	Suceava		Romania
31	Clinic of Oncology - Radiotherapy	Tg. Mures		Romania	540141

Sponsors and Collaborators

• Medivation, Inc.

Investigators

• Principal Investigator: Leonard B Saltz, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medivation, Inc.
• ClinicalTrials.gov Identifier: NCT00890305
• Other Study ID Numbers: CT-2008-01; 2009-014593-18
• First Posted: Apr 29, 2009
• Last Update Posted: Jul 8, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by Medivation, Inc.: Metastatic colorectal cancer; FOLFOX chemotherapy
• Additional relevant MeSH terms: Colorectal Neoplasms; Pidilizumab

Study Results

No Results Posted as of Jul 8, 2015