Carcinoma of the Appendix, Colorectal Cancer
Conditions
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
Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression | 9 hours | Time to progression after surgery was recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 60 months after treatment | — |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 26 |
Baseline characteristics
| Characteristic | Chemo 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, Continuous | 51 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 type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 27 |
| serious Total, serious adverse events | 15 / 27 |
Outcome results
Time to Progression
Time to progression after surgery was recorded.
Time frame: 9 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chemo Therapy Followed by Thalidomide | Time to Progression | 0.775 years |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemo Therapy Followed by Thalidomide | Number of Events of Toxicity Graded 3 and 4 | Grade 3 | 17 number of events |
| Chemo Therapy Followed by Thalidomide | Number of Events of Toxicity Graded 3 and 4 | Grade 4 | 4 number of events |
Progression Free Survival
Time frame: 60 months after treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chemo Therapy Followed by Thalidomide | Progression Free Survival | 0.775 years |