Thalidomide in Treating Patients Who Have Undergone Surgery and Chemotherapy for Cancer That Has Spread Throughout the Abdomen Due to Colorectal Cancer or Appendix Cancer

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00310076
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 29
• Location: 1
• Arm: 1
• Duration (Months): 119
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

RATIONALE: Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving thalidomide after surgery and chemotherapy may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well thalidomide works in treating patients who have undergone surgery and received chemotherapy directly into the abdomen by hyperthermic perfusion for cancer that has spread throughout the abdomen due to colorectal cancer or appendix cancer .

Condition or Disease	Intervention/Treatment	Phase
Carcinoma of the Appendix; Colorectal Cancer	Drug: thalidomide; Procedure: surgery	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine time to progression from surgery in patients who have undergone cytoreductive surgery and intraperitoneal hyperthermic chemotherapy for peritoneal carcinomatosis or adenomucinosis secondary to colorectal or appendiceal cancer treated with adjuvant thalidomide.

Secondary

• Estimate progression-free survival probability of patients treated with this regimen.

• Obtain toxicity data for patients receiving long-term oral thalidomide therapy.

OUTLINE: Patients receive oral thalidomide once daily on days 1-28. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 12 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Adjuvant Thalidomide Following Cytoreductive Surgery and Intraperitoneal Hyperthermic Chemotherapy for Peritoneal Carcinomatosis or Adenomucinosis From Colorectal/Appendiceal Cancer
• Study Start Date: Oct 1, 2002
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chemo therapy followed by thalidomide After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.	Drug: thalidomide; Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.; Procedure: surgery; Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy

Outcome Measures

Primary Outcome Measures

1. Time to Progression [9 hours]

   Time to progression after surgery was recorded.

Secondary Outcome Measures

1. Progression Free Survival [60 months after treatment]

2. Number of Events of Toxicity Graded 3 and 4 [up to 60 months]

   Adverse events with Common Toxicity Criteria grades of 3 and 4 are reported

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Pathologically confirmed peritoneal carcinomatosis or adenomucinosis secondary to colorectal or appendiceal cancer

• Underwent cytoreductive surgery and intraperitoneal hyperthermic chemotherapy (IPHC) within the past 12 weeks

• Patients with residual disease or no evidence of disease after IPHC are eligible

• No extra-abdominal disease or parenchymal liver metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-3

• Free of infection or postoperative complications

• Hemoglobin > 8.0 g/dL

• Absolute neutrophil count > 1,000/mm³

• Platelet count > 100,000/mm³

• PTT or PT < 1.5 times normal (except in patients who are receiving therapeutic anticoagulant therapy for non-related medical conditions, such as atrial fibrillation)

• Bilirubin < 1.5 mg/dL OR direct bilirubin ≤ 1.0 mg/dL (for patients with Gilbert's syndrome)

• AST/ALT ≤ 2.5 times normal

• Serum creatinine < 2.0 mg/dL

• No peripheral neuropathy > grade 1, except localized neuropathy due to a mechanical cause or trauma

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use 2 effective methods of contraception for 4 months prior to, during, and for 4 months after treatment with thalidomide

• No history of hepatic cirrhosis

• No history of severe hypothyroidism

• No history of medical problem such as severe congestive heart failure or active ischemic heart disease

• No other malignancy within the past 5 years except nonmelanoma skin cancer

• No known history of deep vein thrombosis or pulmonary embolus

PRIOR CONCURRENT THERAPY:

• More than 4 weeks since prior chemotherapy, biologic therapy, or radiotherapy (except for IPHC)

• No other concurrent systemic therapy

• No concurrent high level sedatives

• No concurrent sedating "recreational" drugs or alcohol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096

Sponsors and Collaborators

• Wake Forest University Health Sciences
• National Cancer Institute (NCI)

Investigators

• Study Chair: Perry Shen, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT00310076
• Other Study ID Numbers: CDR0000466311; CCCWFU-59202; CCCWFU-BG02-406; CELGENE-CCCWFU-59202
• First Posted: Apr 3, 2006
• Last Update Posted: Aug 23, 2018
• Last Verified: Jul 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wake Forest University Health Sciences: carcinoma of the appendix; stage II colon cancer; stage III colon cancer; stage IV colon cancer; recurrent colon cancer; stage II rectal cancer; stage III rectal cancer; stage IV rectal cancer; recurrent rectal cancer
• Additional relevant MeSH terms: Colorectal Neoplasms; Thalidomide

Study Results

Participant Flow

Arm/Group Title	Chemo Therapy Followed by Thalidomide
Arm/Group Description	After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Period Title: Overall Study
STARTED	29
COMPLETED	26
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Chemo Therapy Followed by Thalidomide
Arm/Group Description	After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Overall Participants	26
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	25 96.2%
>=65 years	1 3.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51 (10)
Sex: Female, Male (Count of Participants)
Female	13 50%
Male	13 50%
Region of Enrollment (participants) [Number]
United States	26 100%

Outcome Measures

1. Primary Outcome

Title	Time to Progression
Description	Time to progression after surgery was recorded.
Time Frame	9 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chemo Therapy Followed by Thalidomide
Arm/Group Description	After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Measure Participants	26
Median (95% Confidence Interval) [years]	0.775

2. Secondary Outcome

Title	Progression Free Survival
Time Frame	60 months after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chemo Therapy Followed by Thalidomide
Arm/Group Description	After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Measure Participants	26
Median (95% Confidence Interval) [years]	0.775

3. Secondary Outcome

Title	Number of Events of Toxicity Graded 3 and 4
Description	Adverse events with Common Toxicity Criteria grades of 3 and 4 are reported
Time Frame	up to 60 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chemo Therapy Followed by Thalidomide
Arm/Group Description	After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Measure Participants	26
Grade 3	17
Grade 4	4

Adverse Events

Time Frame	up to 60 months
Arm/Group Title	Chemo Therapy Followed by Thalidomide
Arm/Group Description	After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
All Cause Mortality
	Chemo Therapy Followed by Thalidomide
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Chemo Therapy Followed by Thalidomide
	Affected / at Risk (%)	# Events
Total	15/27 (55.6%)
Blood and lymphatic system disorders
Hemorrhage	1/27 (3.7%)	1
Cardiac disorders
Cardiac Dysrhythmias	1/27 (3.7%)	1
Cardiovascular/General-other	1/27 (3.7%)	1
Thrombosis/Embolism	2/27 (7.4%)	2
Gastrointestinal disorders
Constipation	2/27 (7.4%)	2
Diarrhea	1/27 (3.7%)	1
other gastrointestinal	1/27 (3.7%)	1
Nausea	3/27 (11.1%)	3
Vomiting	3/27 (11.1%)	3
General disorders
Dysphagia, esophagitis, odynophagia	1/27 (3.7%)	1
Fatigue	1/27 (3.7%)	1
Hypertension	1/27 (3.7%)	1
Hypotension	1/27 (3.7%)	1
Hypoxia	1/27 (3.7%)	1
Weight Gain	2/27 (7.4%)	2
Infections and infestations
Infection with unknown ANC	3/27 (11.1%)	3
Infection/Febrile Neutropenia-Other	1/27 (3.7%)	1
Investigations
Creatinine	1/27 (3.7%)	1
Hemoglobin	1/27 (3.7%)	1
Hypokalemia	2/27 (7.4%)	2
Hypomagnesemia	1/27 (3.7%)	1
Metabolism and nutrition disorders
Dehydration	1/27 (3.7%)	1
Nervous system disorders
Neurosensory	5/27 (18.5%)	5
Pain-other	2/27 (7.4%)	2
Psychiatric disorders
Neuro-mood	2/27 (7.4%)	2
Neuro-motor	2/27 (7.4%)	2
Renal and urinary disorders
Ureteral Obstruction	1/27 (3.7%)	1
Respiratory, thoracic and mediastinal disorders
Cough	1/27 (3.7%)	1
Dyspnea	1/27 (3.7%)	1
Other (Not Including Serious) Adverse Events
	Chemo Therapy Followed by Thalidomide
	Affected / at Risk (%)	# Events
Total	27/27 (100%)
Ear and labyrinth disorders
Auditory/Ear-Other	2/27 (7.4%)	2
Endocrine disorders
Endocrine Other	3/27 (11.1%)	3
General disorders
Anorexia	3/27 (11.1%)	3
Alopecia	5/27 (18.5%)	5
Dizziness/vertigo	4/27 (14.8%)	4
Insomnia	2/27 (7.4%)	2
Weight Loss	4/27 (14.8%)	4
Hot flashes/flushes	2/27 (7.4%)	2
Somnolence	5/27 (18.5%)	5
Infections and infestations
Infection-Other	2/27 (7.4%)	2
Investigations
Leukocytes	10/27 (37%)	10
Alk Phos	8/27 (29.6%)	8
Absolute Neutrophil Count	3/27 (11.1%)	3
Hyperglycemia	14/27 (51.9%)	14
Hypoglycemia	2/27 (7.4%)	2
Hypocalcemia	8/27 (29.6%)	8
Hyponatremia	2/27 (7.4%)	2
Coagulation Other	2/27 (7.4%)	2
Hypoalbuminemia	4/27 (14.8%)	4
Serum glutamic pyruvic transaminase	7/27 (25.9%)	7
Serum glutamic oxaloacetic transaminase	5/27 (18.5%)	5
Hyperkalemia	4/27 (14.8%)	4
Hypernatremia	3/27 (11.1%)	3
Fever in the absence of neutropenia	2/27 (7.4%)	2
Metabolism and nutrition disorders
Edema	3/27 (11.1%)	3
Nervous system disorders
Neurologic Other	9/27 (33.3%)	9
Skin and subcutaneous tissue disorders
Dermatological	7/27 (25.9%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.