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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

Phase II Trial of Adjuvant Thalidomide Following Cytoreductive Surgery and Intraperitoneal Hyperthermic Chemotherapy for Peritoneal Carcinomatosis or Adenomucinosis From Colorectal/Appendiceal Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00310076
Enrollment
29
Registered
2006-04-03
Start date
2002-10-31
Completion date
2012-09-30
Last updated
2018-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma of the Appendix, Colorectal Cancer

Keywords

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

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 .

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.

Interventions

DRUGthalidomide

Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.

PROCEDUREsurgery

Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Time to Progression9 hoursTime to progression after surgery was recorded.

Secondary

MeasureTime frameDescription
Progression Free Survival60 months after treatment
Number of Events of Toxicity Graded 3 and 4up to 60 monthsAdverse events with Common Toxicity Criteria grades of 3 and 4 are reported

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
26
Total26

Baseline characteristics

CharacteristicChemo Therapy Followed by Thalidomide
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
25 Participants
Age, Continuous51 years
STANDARD_DEVIATION 10
Region of Enrollment
United States
26 participants
Sex: Female, Male
Female
13 Participants
Sex: Female, Male
Male
13 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
27 / 27
serious
Total, serious adverse events
15 / 27

Outcome results

Primary

Time to Progression

Time to progression after surgery was recorded.

Time frame: 9 hours

ArmMeasureValue (MEDIAN)
Chemo Therapy Followed by ThalidomideTime to Progression0.775 years
Secondary

Number of Events of Toxicity Graded 3 and 4

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

Time frame: up to 60 months

ArmMeasureGroupValue (NUMBER)
Chemo Therapy Followed by ThalidomideNumber of Events of Toxicity Graded 3 and 4Grade 317 number of events
Chemo Therapy Followed by ThalidomideNumber of Events of Toxicity Graded 3 and 4Grade 44 number of events
Secondary

Progression Free Survival

Time frame: 60 months after treatment

ArmMeasureValue (MEDIAN)
Chemo Therapy Followed by ThalidomideProgression Free Survival0.775 years

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026